Longevity Industry Jobs

Mission of external quality.

• We serve our patients through external partnerships because access to quality products is every patient’s right.
• We leverage external partners in order to offer flexibility to our internal capacity at the right cost and quality.
• We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide.
• We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.

Main Purpose of the Position

• Provide quality and compliance oversight for external GxP suppliers including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and quality agreement requirements.
• Serve as the Quality Point of Contact (PoC) for designated suppliers and participate as a key member of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning.

Technical Job Responsibilities

• Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Roche and Health Authority audits, complex investigations, market complaints, and regulatory submissions.
• Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements.
• Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate.
• As applicable, manage all required activities to support Make Assess Release (MAR) of commercial medicinal products including approval of master process documentation, resolution of investigations, assessment of changes, and monitor and report GxP Supplier quality performance.
• As applicable, release, reject or quarantine commercial medicinal products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within the area of responsibility per applicable Swissmedic and Roche requirements on behalf of the Responsible Person (RP).
• As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs.
• As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of continuous inspection readiness.
• As applicable, manage or lead technical transfers for manufacturing, testing, packaging, and product launches.
• As applicable, support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements
• Functional Job Responsibilities
• Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations are aligned with Roche objectives.
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.
• Sign documents as authorized and described by Roche policies, procedures and job descriptions.
• Be accountable for behaviors described in Roche’s Code of Conduct.
• Deliver business outcomes in support of departmental objectives.
• Maintain and communicate work priorities to meet goals and timelines.
• Timely complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.
• Communicate new and updated regulatory requirements and applicable Roche expectations to GxP suppliers as applicable, and evaluate systems in place.
• Perform other quality related activities and projects in order to ensure quality and compliance and enable continuous improvement.
• Identify, support and/or lead continuous improvement initiatives that may benefit External Quality and other organizations.
• As applicable, deputize for the GxP Supplier Management Chapter Lead or a peer and assist with their duties if and when required.
• May mentor and/or coach colleagues within and outside the organization.

Minimum Qualifications And Skills

• B.A. or B.S. degree in life sciences or equivalent
• 8-10 years of experience in the pharmaceutical or related industry. Experience with quality management of GxP service providers is a plus.
• Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to GxP suppliers.
• Proven ability to influence across cultures and functional reporting lines, and to drive continuous improvement initiatives
• Demonstrate agile mindset and behavior.
• Highly competent in MS office or Google Suite applications including Excel, Powerpoint, Word, and MS Project, etc.
• Ability to communicate clearly and professionally both in writing and verbally.
• Fluency in oral and written English is a must. Additional language skills are a plus.
• This position may require up to 10% domestic and/or international travel.

Relocation is not available for this position.

Employee must be located near one of the Genentech sites listed. Candidates local to Oceanside preferred.

The expected salary range for this position based on the primary location of Oceanside, CA is $137,700 and $239,700.Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

The Therapeutic Area Medical Science Liaison (TA MSL) is a credible scientific partner responsible for providing clinical and health economic information related to disease states and the appropriate utilization of Genentech medicines (approved and pipeline). This field-based position will engage with healthcare providers, population health decision makers, and patients within their region(s), to further patient outcomes aligned with the overarching objectives of Genentech. In collaboration with their regional partners, TA MSLs are accountable for co-creating the local medical strategy and delivering for their customers. In addition, TA MSLs may be responsible for covering multiple medicines, as well as engaging in broad scientific discussions around patient outcomes and total cost of care, resulting in rich customer insights shared with key stakeholders across the organization.

Key Responsibilities/Accountabilities:

• Ensure an end to end customer experience for TA specific customers within the region
• Demonstrate deep scientific expertise about assigned molecules/products, franchise(s) and overall therapeutic area(s) to exchange relevant information and insights with top tier thought leaders and healthcare decision makers within a region
• Build, cultivate, and leverage relationships with key external scientific and medical customers and organizations in their region(s) to ensure strong understanding of evolving healthcare trends across the relevant therapeutic area landscape
• Demonstrate proficiency in topics beyond scientific exchange such as value / cost of care discussions, hospitalizations, risk of progression, drug pricing pressures, reimbursement education, and AE management
• Engage in continuous independent learning within the therapeutic area they represent and actively attend and participate in upskilling programs related to assigned molecules, products, disease states and relevant business topics
• Respond to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Genentech guidelines, policies & procedures
• Build and cultivate important working relationships across field partners to ensure an enterprise approach when working with customers. Be accountable to the regional team to shape and execute on local medical strategies within planned timelines
• Depending on regional needs and priorities, may be asked to serve in a Medical Affairs Executive Director (MED) role with specific customers
• Identify and bring insights back in house to Genentech stakeholders through efficient and effective use of CRM system
• Assist with Phase I - IV sponsored and supported clinical trials, health economic outcomes research, other TA specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance
• Share clinical and value-based expertise in the development and management of clinical and scientific communications for customers to include publications, conference data, and educational materials, as well as for internal Genentech communications and materials to be used in training and development activities
• Ensure assigned goals and objectives are met and that assigned projects and other work are completed on time, with high quality, and within budget

Qualification:

• Advanced Clinical/Science Degree required (e.g., MD, PharmD, PhD, MSN, NP, PA etc.). BSN with extensive clinical experience may be considered.

Knowledge:

• GCP (Good Clinical Practice) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) proficient
• In-depth knowledge of Phase IV/post-marketing drug development is preferred
• Relevant therapeutic area knowledge, dependent on customer base
• Comprehensive understanding of product and safety profiles
• Understanding of managed care, health economics, healthcare reimbursement, managed care customers and the distribution channels relevant to pharmaceutical/biotechnology organizations
• Familiarity with the current legal and regulatory landscape pertinent to the pharmaceutical/biotechnology industry

Required Experience:

• Minimum of 5 years related work experience (clinical, managed care, or industry experience)
• Prior experience as a field medical science liaison is preferred
• 2 or more years’ clinical or health economic research experience (either in industry or in another, related setting) is preferred
• 2 years' experience in therapy area is preferred

Skills:

• Ability to learn other disease or product areas as business needs and product life cycles change
• Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion
• Proven track record of meeting or exceeding objectives and goals
• Strong attention-to-detail
• Learning mindset, open to training and becoming an expert across customer types or multiple therapeutic areas
• Outstanding business acumen; knows the industry, Genentech's business model and value proposition, key competitors and other marketplace factors/dynamics
• Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills; proven ability to effectively and quickly achieve conflict resolution with affected parties and work in a cross functional environment
• Knows how to summarize and communicate complex information and business objectives in a concise and effective way for important presentations and decisions
• Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities
• In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening)
• Business travel, by air or car, is required for regular internal and external business meetings (up to 70% of time)
• This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business

This is a field-based position. Must be willing to travel overnight to meet with customers, internal stakeholders, and attend relevant conferences.

Relocation will NOT be provided for this role. We do require this person reside within, or potentially adjacent, to the established territory.

Operating Principles:

• Put Patients First: I always act as if patients I know are in the room and do what's best for them.
• Follow the science: I seek answers through experiments, data and debate, and act on facts.
• Act as one team: I care, collaborate and commit without boundaries, and trust others to do their part.
• Embrace differences: I seek diverse perspectives, invite opposing views, and challenge myself and others.
• Accelerate learning: I push to learn new things even if difficult, and openly share my successes and failures.
• Simplify radically: I eliminate complexity, reuse with pride, and accomplish more with less.
• Make impact now: I take accountability to do what's right, deliver value fast, and don't wait for certainty.
• Think long term: I choose actions today that benefit future generations.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

The Therapeutic Area Manager (TAM) is integral to successfully delivering this vision, working closely with healthcare providers. The TAM deeply understands the specific needs of healthcare practitioners in their therapeutic area to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care.

The TAM is empowered to own the business for their TA within the ecosystem and to optimize as appropriate; focused on improving the customer and patient experience across the care continuum. They will leverage other ecosystem and organization experts to provide customers with the information they need about products to make decisions that support enhanced patient outcomes, and to influence the ecosystem business strategy. The TAM will represent all relevant products and indications within the designated Therapeutic Area.

In alignment with the ecosystem and customer strategic plan, the TAM is accountable for driving on-label clinical demand to ensure HCPs identify the right medication for the right patient.

In addition, they are responsible for collecting ecosystem insights and trends and being a primary conduit between an ecosystem, the Squads and marketing to support the national strategy at a local level. The TAM will represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials.

Key Accountabilities

• Serve as primary point of contact for their therapeutic area for their customers in the ecosystem. Address and identify opportunities for pulling through ecosystem and TA squad strategies at the point-of-care
• Leads end to end experience for assigned customers/ accounts and drives clinical and non-clinical decision making at the point of care working with healthcare practitioners on topics ranging from clinical education, to screening, testing, palliative care, and non-clinical education (reimbursement, contract awareness, advocacy, etc)
• Deep understanding of the overall and unspecified abstract needs of patients, all customer archetypes, and Genentech, including goals and challenges across clinical and non-clinical domains
• Proactively identifies opportunities and develops solutions for multiple complex accounts or a few large and critical accounts (academic, delivery network focused and TA specialty accounts) within and across ecosystems
• Develops solutions to unusually complex problems relative to own scope (accounts, customer, territory) using multiple dynamic sources of information
• Deliver education to HCPs regarding product information, appropriate use, and dosing and administration based on FDA approved product information and formulary/pathways/guidelines (e.g. one on one interactions, in-services, identification of opportunities for peer-to-peer programming, etc.). Effectively triage to USMA experts as appropriate
• Address product acquisition (contract awareness, etc), and address supply matters through coordination of distribution issues, and managing spoilage and returns
• Ensure product access to provide proactive (and de-identified) education on patient assistance, reimbursement resources. Triage to HD and FRM as appropriate
• Keep abreast of customer and healthcare industry trends. Initiates development actions to constantly adapt and grow capabilities to increase impact
• Represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials
• Lead, act and live our Operating Principles in all aspects of work

Qualifications

• Business, scientific or clinical degree, Bachelor’s degree level at minimum
• Previous cross-functional industry experience in commercial life sciences (pharma or biotechnology) or related industry engaging with key healthcare ecosystem players (e.g., payers, health systems), is required
• 6 or more years experience working in a sales role with HCPs, ideally representing multiple products and working across a complex healthcare system environment
• Clinical nurse or Advanced Practice Nurse (APN) experience highly valued
• Ability to work in an ambiguous environment undergoing transformation is a strong plus
• Proven track record in coaching, training and/or mentoring peers or others as assigned; helping such others to better meet or exceed their goals, targets and other responsibilities
• Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals
• Self starter; ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem
• Ability to assimilate and communicate complex clinical and product information
• Knowledge of and ability to successfully addressing operational issues in the delivery of healthcare products to patients, such as reimbursement and supply
• Understanding of external laws, codes and company policies that apply to the healthcare industry

Our Operating Principles:

Put Patients First: I always act as if patients I know are in the room and do what's best for them.

Follow the science: I seek answers through experiments, data and debate, and act on facts.

Act as one team: I care, collaborate and commit without boundaries, and trust others to do their part.

Embrace differences: I seek diverse perspectives, invite opposing views, and challenge myself and others.

Accelerate learning: I push to learn new things even if difficult and openly share my successes and failures.

Simplify radically: I eliminate complexity, reuse with pride, and accomplish more with less.

Make impact now: I take accountability to do what's right, deliver value fast, and don't wait for certainty.

Think long term: I choose actions today that benefit future generations.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

This is a field-based position and overnight travel may be required. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

We are looking for a highly motivated engineer to take on the role of the “IT OT Specialized Application Lead” as part of the Site IT OT Organization in a 24x7 Good Manufacturing Practice (GMP) environment.

The successful candidate will be:

• Site Owner of “Customized Applications” that interface with Manufacturing System Platforms such as OSI PI (Plant Historian), Syncade (MES), DeltaV (Distributed Control System), PLC's, Lab Data Systems (Smartline Data Cockpit) using OPC or other middleware. Examples of custom applications include: reports/reporting tools, dashboards.
• Skilled at scripting and programming preferably in a manufacturing systems environment (Java, C++, Python, PowerShell).
• Support Lead for custom applications but also knowledgeable in Operational Technology Systems.
• May eventually expand the role to become a Regional role for multiple sites supporting IT OT operating model evolution.

What you will be working on:

• Development and Lifecycle management of the customized applications and related systems.
• Support the implementation of OT standards and best practices across all sites.
• Support commissioning and startup activity of new process control systems and manufacturing systems (Syncade, DeltaV, PLC’s, OSI PI historian, etc).
• Support the execution of computer system validation and control system lifecycle management.
• Develop and maintain GMP/Non-GMP design documentation and engineering diagrams.
• Execute testing and installation of system/database patches, upgrades, and new releases.
• Troubleshoot and resolve incidents and problems associated with the system/databases and applications.
• Execute implementation and delivery of projects on-site IT OT Product Portfolio.
• Operate and execute change control process for system deployment and release management of system/database software across Good Manufacturing Practice (GMP) validated and non-GMP environments.

Requirements / Qualifications:

• Bachelor’s degree in Engineering, Computer Science, or equivalent experience.
• A minimum of 5 years systems engineer experience involved in the design, implementation, and/or support of automation systems, preferably in a regulated (Pharmaceutical) industry. Candidates with 8-10 years of relevant experience are preferred.
• 24X7 support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required.
• Extensive experience with scripting and programming in various languages (Java, C++, Python, PowerShell) preferably in a Manufacturing Systems environment.
• Experience with scripting and programming in various languages (Java, C++, Python, PowerShell).
• Experience with Microsoft Windows Server operating system, Microsoft SQL Server, and development tools.
• Experience with Emerson DCS DeltaV, MES Syncade, OSIsoft PI, Rockwell Automation AssetCentre, and various OPC architectures.
• Onsite at Oceanside, CA, required (no remote).
• Relocation assistance will be considered for exceptional candidates.

The expected salary range for this position based on the primary location of California is $104,520 to $141,778. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

#ITcareers

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

We are seeking a motivated and experienced Technical Development Principal Scientist to join the Protein Analytical Chemistry Department at Genentech. The successful candidate will work in a highly collaborative team environment to lead and deliver analytical method development, product variant characterization, and control strategies for late stage (phase III to commercial) protein therapeutic development. Additionally, the successful candidate will serve as an analytical representative on cross-functional project teams collaborating with colleagues in Cell Culture, Purification, Pharm Development, Quality and Regulatory groups.

Responsibilities

• Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods to support protein characterization, process development, comparability assessment, method qualification/validation, and other late stage analytical activities.
• Perform physicochemical characterization of protein therapeutics (such as antibody drugs and new protein drug modalities) to determine critical quality attributes.
• Provide technical support of analytical method qualification, validation, and transfer activities.
• Author and review technical development documents and relevant sections of health authority filings.
• Define and perform comparability assessment to support late stage clinical development and commercial launch programs.
• Assist in defining and executing phase appropriate analytical control strategy to enable CMC development timelines.
• Hands-on, technical execution in the laboratory while providing mentorship to junior colleagues.
• Ensure timely analytical support for bioprocess/formulation development and process validation activities.
• Maintain timely and accurate lab records consistent with good documentation practices.
• Serve as a team representative and provide analytical knowledge and expertise to cross-functional teams.

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline plus a minimum of 3+ years analytical development experience for protein therapeutics in the biotech/biopharma industry; or BS/MS with a minimum of 8+ years of experience.
• Demonstrated track record of successful analytical method development and product characterization for late stage protein therapeutic development.
• In-depth knowledge and extensive hands-on experience in developing a wide array of analytical protein characterization methods (e.g. HPLC-based methods, capillary electrophoresis, LC/MS peptide mapping, etc.).
• Prior experience with Phase III IND and BLA authoring considered a plus.
• Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams.
• Excellent critical thinking, scientific problem-solving, and organizational skills.
• Excellent oral and written communication skills.
• Motivated, detail-oriented, scientifically driven individual with a creative approach to problem solving.

Please note this role may be filled as a Principal Scientist or Scientist III depending on a combination of education, experience and competencies.

Relocation benefits are available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco is $119,600 - $222,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

#ptd

#ptcareers

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Genentech is offering an exciting opportunity for the right individual to join Genentech’s Hillsboro Individualized Therapies (HIT) team, working to bring new medical advancements from development stages to commercial manufacturing. This is an exciting opportunity to work closely with emerging technology including but not limited to individualized DNA/RNA therapies, Cell therapies, and Stem Cell therapies. This is the start-up headquarters for Genentech’s individualized and cell therapies division where we will establish the industry standard. As a member of the team you would be responsible for supporting multi-phase technology transfers and production, including:

• Working with scientists and development leads to establish a framework for developing manufacturing processes, controls, and procedures, and transferring these new technologies to the site.
• Working with our Manufacturing Sciences and Technology (MSAT) team to qualify and validate new equipment and processes.
• Owning the development of all batch related documentation including manufacturing batch records, standard operating procedures, training materials, and associated forms.
• Collaborating with compliance and quality members to assess process risks and establish appropriate controls for product safety and efficacy.
• Works collaboratively in a team environment with end to end responsibility for all aspects of manufacturing operations for clinical and/or commercial products. The person has the expertise to run all operations, including but not limited to: preparation of components, solutions/buffer preparation, cell culture, filtration, chromatography, formulation, fill- finish, and other aseptic operations.
• Collaborating cross-functionally to find innovative solutions for process implementation.
• Perform all process simulations to demonstrate successful process implementation, for development, for training, and for enabling clinical and commercial supply.
• Supporting all activities necessary for GMP operations and commercialization.
• Utilizing LEAN methodologies to realize improvements /efficiencies in the processes, increase uptime of equipment, debottleneck the processes, improve yields, and implement standard work to maximize productivity.
• Utilize single-use technology, new analytical techniques, and digital manufacturing systems to maximize capacity of a best in class bioprocess facility.
• Owning process deviations. You will perform initial triage of unplanned events, act as the unplanned event owner, leading root cause analysis when deviations occur, and developing corrective actions to prevent recurrence.
• Promoting a learning culture by training on new processes / procedures and training others.
• Travel will be required to support technology transfers and training purposes. May require extended duration trips depending on the needs of the project.

This is a multi-faceted role offering variety in daily responsibilities and project-based work. Therefore, the ability to self-manage tasks and meetings to hit project timelines is a must. This role also requires engagement with other departments including quality, compliance, maintenance, engineering, and analytical development technology to collect the right information for the best decision-making.

Qualifications / Requirements:

• Bachelor’s degree and 1 year of experience or an equivalent combination of education and experience
• Experience with technical writing / documentation authoring
• Support equipment operations including qualification, validation, establishing equipment procedures, supporting maintenance, routine operations, and advanced troubleshooting analysis and process operation
• Must be computer literate. GSuites is a must.
• Experience working in a commercial or clinical GMP environment
• Must be able to travel domestically and internationally to development sites
• Must be flexible to work off shift hours to support business needs

Preferred:

• Degree in cellular or molecular biology or engineering
• Previous experience with individualized cell and/or gene therapies is strongly preferred; applicants with cell/gene therapy experience will be given preference
• Experience driving continuous improvement / using LEAN methodologies
• Experience with data analysis software, ERP systems, Manufacturing Execution Systems, and quality management systems
• Benchwork/lab work experience preferred (working in biosafety cabinets, pipetting, PCR, purification, open and closed cell culture, aseptic technique, etc)
• Experience managing deviations in a GMP environment or supporting impact assessments
• Knowledge of Health Authority requirements

Physical Requirements:

• When working in the clean rooms, you will be required to wear Genentech-provided safety shoes
• You should be able to lift up to 25lbs on rare occasions
• You will work in a clean room environment; you will be required to gown in the form of hospital scrubs, bunny suits, gloves, hair net, mask, safety glasses, hearing protection.
• All candidates must pass a vision acuity and color discrimination test
• Must complete periodic physical examinations to identify medical conditions which pose a risk to Grade C or higher operation
• No makeup or jewelry can be worn when working in the clean room environment
• You may work with hazardous materials and chemicals

Relocation benefits have been approved for this posting.

#cellandgenetherapycareers#

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Note: this is a 1- year contract position with a proposed start date of July 2023 with an option to extend as business dictates.

This position is part of the Individualized Medicines Team in the Pharma Cell and Gene Therapy Group (PTC) responsible for the process development, manufacture and supply of personalized immunotherapies in collaboration with our global partners.

We are seeking a highly motivated team member to serve as a Product Owner (PO) in the PTC Bioinformatics group. This role will contribute to the ongoing effort to develop a production grade computational pipeline and a GxP qualified, compliant cloud infrastructure to power neoantigen discovery and NGS based analytical workflows in support of CGT manufacturing. The team collaborates with Research (gRED), IT, Quality, and PTC Data Analytics colleagues to advance our software development efforts by using an Agile/Scrum framework. The PO is a key role in the SCRUM framework responsible for optimizing the value of work the Development Team performs and leading the team into successful delivery of the platform. The PO will own the team’s product vision, delivery strategy, backlog grooming/prioritization, release planning and ensure all pipeline stakeholders are connected to the development effort.

Required Qualifications:

• Master's degree in a science, engineering or mathematics related discipline
• At least 2 years of relevant experience in the biotech/pharma industry
• Proficiency in coding in R, python or other programming languages
• Familiarity with bioinformatics workflows, preferably oncology pipelines
• Experience with Agile software development and SCRUM team framework
• Experience with supporting development of GxP cloud solutions
• Experience with software development and software quality best practices.
• Excellent communication skills and ability to thrive in a matrix team environment are required

Nice to have experience:

• Agile/Scrum certification
• Prior experience with the drug development process
• Experience with Agile CSV Methodologies
• 3 or more years of relevant experience in the biotech/pharma industry

#ptcareers

#cellandgenetherapycareers#

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as using new technologies.

Mission:

This position, based in Genentech's South San Francisco, California facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate will report to the Site Head of IT OT, an organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies.

As part of the South San Francisco IT OT team, you will have System Owner and local Product Manager accountabilities for the South San Francisco Manufacturing Execution System (MES), maintaining roadmaps and lifecycle plans, developing proposals, managing related backlogs, leading and/or participating in Build/Run Squads, and ensuring the support of Product Transfers and Make/Assess/Release in a 24x7 Good Manufacturing Practice (GMP) environment. As part of the Site Team and larger Global IT OT organization, you will also be expected to contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape.

What you’ll be working on:

• Co-create MES strategy and roadmap with business partners (Business Process Owner/Manager, Site Stakeholders and MES Core Product Owner) in collaboration with IT Partners (Architects, Global Infrastructure, Business Analysts and MES Core Product Manager) plus external vendors.
• Represent and mitigate MES dependencies as related global systems evolve their business processes and technologies (e.g. SAP upgrade & LIMS replacement).
• Work to identify opportunities to create additional value and improve business processes and patient outcomes, maximize the benefits of standardization of technologies and leverage across sites.
• Determine business criticality and product quality requirements, and in collaboration with Delivery Service Managers, ensure appropriate service levels, Disaster Recovery procedures, governance, change management, compliance and operational support.
• Lead or coordinate technical discussions and vendor negotiations.
• Lead proposal development for local and global digital governance bodies, collaborate with Site IT Business Partner to meet the needs of the South San Francisco Manufacturing.
• Through Agile delivery model, provide leadership, technical expertise and local implementation experience as a member of Build and Run Squads.
• In collaboration with IT Business Partners, monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release.

The ideal candidate:

Has business domain knowledge for the following area(s)

• Biopharmaceutical or similar Manufacturing domain.
• Knowledge of informational and operational technologies (IT OT), MES integration to enterprise systems.
• Knowledge of Manufacturing Execution System, Manufacturing Automation, MES integration with enterprise systems like LIMS, Data Historian, ERP etc.
• Knowledge of new product introduction, supply chain and manufacturing operations as applicable to MES.
• Keep abreast of key Manufacturing IT trends and be curious - Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
• Nurtures and develops a business savvy consultative and value-driven partnership.
• Champions PT Informatics Product Management Strategy in implementing global Core Platforms.
• Exhibits the behaviors of a Lean-Agile Leader with a Lean-Agile Mindset.
• Exhibits intellectual curiosity and integrity and has a strong passion to bring value-adding technology to the business.
• Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.
• Entrepreneurial mindset e.g. "automating automation"

Requirements:

• Bachelor’s Degree in Informatics, Engineering or equivalent.
• 5+ years of experience implementing and managing MES solutions, Highly desirable Emerson Syncade, Pharma Suite or extensive experience from other platforms that will accelerate learning on those platforms.
• Must have experience in life sciences Manufacturing domain.
• Prior experience in working closely with IT OT providers/vendors.
• Availability to travel up to 10%. Must be open to both domestic and global travel.
• Relocation assistance is not available for this position.

The expected salary range for this position based on the primary location of South San Francisco, California is $96,000 to $160,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

#ITcareers

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

The Protein Analytical Chemistry department prides itself on expertise and leadership in the area of process related impurities. We have an exciting opportunity for a talented scientist to join our team.

The position is focused on evaluating protein-based drug product for leachables, and characterizing extractables from a range of container systems and process equipment. The work will involve working with contract research organizations (CROs), designing methods to characterize and quantitate extractables and leachables, collecting and interpreting data for a wide variety of protein-based therapeutics, and thoroughly documenting results. A successful candidate will be capable of applying advanced GC-MS and LC-MS methods to evaluate small molecule and impurities in complex solutions. Direct experience applying these analytical methods to impurities or leachables analyses is required. The ability to become proficient in other methods, such as ICP-MS, is important.

This job requires the strong organizational skills and the capacity to manage multiple simultaneous projects. The ability to plan, schedule, and track work for internal and external teams is essential. Documentation of results and authoring of protocols and summary reports are part of the position, so excellent written communication abilities are needed.

Key Job Functions

• Plan and execute testing of protein-based drug product for small molecule leachable content.
• Evaluate in-house extractables data from container systems and process equipment.
• Review leachables data from contract research organizations (CROs).
• Review extractables data from vendors and other external sources.
• Provide SME knowledge in the areas of GC-MS and LC-MS.
• Help support other analytical methods, such as ICP-MS.
• Troubleshoot instruments and methods.
• Communicate results to project teams and advise on the proper experimental design for E&L testing.
• Author protocols, summary reports, and regulatory submissions.

Who You Are

• Ph.D in Chemistry, Biochemistry, or related scientific field, or equivalent combination of Bachelor's/Master’s and experience.
• 5+ years of experience and an advanced knowledge of small molecule LC-MS and GC-MS.
• Experience with extractables and leachables as related to primary container closure and process equipment.
• Strong organizational skills
• The ability to work well with a variety of project teams.
• A successful track record of written communication.

The expected salary range for this position based on the primary location of South San Francisco is $95,400 - $177,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are available for this job posting.

#PTD

#PTCareers

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

The Computational Biology and Neuroscience departments at Genentech are looking for an exceptional computational scientist to study the interactions between sensory neurons and the immune system. While this position is primarily computational, the project is highly collaborative, with regular interactions across both laboratory and computational teams. The successful applicant will have the opportunity to work closely with computational colleagues to analyze and perform integrative computational analyses leveraging multimodal high dimensional data to explore the different cellular populations that could play critical roles in sensory-immune interactions. In particular, we are very interested in understanding the role of the immune system in mediating acute or chronic pain. The applicant will work closely with laboratory colleagues in the design of relevant experiments to develop and validate biological hypotheses. The applicant may also participate in method or technology development, in collaboration with members of the Computational and Neuroscience departments. Scientific insights resulting from this research are expected to be presented at external scientific conferences and published in high impact journals.

Requirements:

• Ph.D. in Computational Biology, Bioinformatics, Biostatistics, Computer Science or related field
• Demonstrated proficiency with R or Python
• Experienced with single-cell omics data analysis (e.g. single-cell RNA-seq, Perturb-seq, 10x multiome)
• Background in Immunology or Neuroscience is a plus
• Demonstrated ability to effectively communicate about complex bioinformatics problems to both technical and non-technical audiences
• Independent, highly motivated, and highly collaborative with the ability to work together with multi-disciplinary teams of computational and laboratory biologists
• Enthusiastic about working in a scientific environment, especially one that is related to drug discovery and development
• Quick learner, are curious about new areas and the opportunity to build expertise, and courageously and creatively take initiative to see your ideas implemented
• Able to perform at a high level in a fast changing and demanding environment

Key members of team that the postdoc will be working with:

https://www.gene.com/scientists/our-scientists/josh-kaminker

https://www.gene.com/scientists/our-scientists/brad-friedman

https://www.gene.com/scientists/our-scientists/david-hackos

For information about the Postdoctoral Program at Genentech, please go to:

https://www.gene.com/careers/university-and-early-career/postdocs

The expected salary range for this position based on the primary location of California is $64,800 and $120,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are available for this job posting.

#postdoc

#gCS

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

The Manufacturing Technical Specialist position at Genentech is the equivalent to and is a part of the engineering job family. This role would be equivalent to an Engineer II/Senior Engineer in our Manufacturing Sciences and Technology organization

The Manufacturing Technical Specialist III/Senior is an integral member of the OSUT (Oceanside Single Use Technology) team in Oceanside.The OSUT is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 3 clinical trials and commercial products. The OSUT will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset. Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual. Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production. The team members will work closely with the existing staff in the stainless steel operations as well as with South San Francisco Clinical Supply Center (CSC).

In this role the qualified individual will be part of the Operations, Process Support and Process Engineering team that starts up the facility. There will be one team that will support the entire process from initial cell bank thaw through bulk freeze. Team members will support manufacturing operations upstream and downstream but will also have responsibility for technical evaluations, troubleshooting, and work with vendors on equipment or consumable design. The candidate will engage with customer groups, network teams and vendors seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.

Responsibilities:

• Technical contact for team, customers and vendors to consult with on new technologies and troubleshooting efforts
• Support troubleshooting efforts on equipment, process, automation in support of release of drug substance material
• Initiate and lead projects that result in implementation and/or optimization of novel methods and technique, including optimizing process performance
• Execute on the floor operations during Clinical and GMP campaigns and Tech Transfers
• Support effective partnerships within & outside of Roche; work closely with CSC for change initiatives
• Develop and deploy robust knowledge sharing experiences; coach and train other team members
• Contribute to achieving results in other organizations across the company
• Member of functional, organizational and cross functional teams/projects
• Enhance safety of the organization through process/equipment improvements
• Part of equipment design and purchase
• Give speaker presentations across departments

Skills and behavior profile:

• Strong behaviors aligned with Pharma Technical (PT) expectations specifically: Lean/Agile, inclusion, collaboration, speaking up, decision making and continuous improvement
• Ability to work in an agile and ambiguous environment
• Commitment to quality and excellence
• Growth mindset with a passion for taking on challenges in order to deliver business value while developing
• Entrepreneurial spirit within a GMP environment
• Ability to challenge the status quo in order to deliver value
• Ability to work with minimal oversight

Job Requirements

• BA/BS in a life science, engineering or equivalent
• Experience in drug substance/bulk biologics experience and single use technology (SUT) preferred
• Understands and has experience working with single use technologies, commercial operational experience is preferred
• Understand current GMP requirements and regulations
• Extensive practical and theoretical expertise in biopharmaceutical manufacturing processes and process improvements
• Ability to work in fast paced dynamic work environment
• Possess excellent interpersonal, communication and collaboration skills
• Strong problem solving and critical thinking skills
• Self-motivated, organized and capable of multitasking

The expected salary range for this position based on the primary location for this position of Oceanside, California is $69,000 - $185,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are provided.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

DeltaV Automation Engineer is an integral part of the Oceanside site and closely connected to the Roche/Genentech Global network. The Oceanside site is a large molecule drug substance facility delivering multiple commercially licensed lifesaving medicines as well as a pivotal/launch site, responsible for delivering Genentech/Roche pipeline products at clinical and commercial launch phases. There are many exciting advancements happening at the Oceanside campus, including constructing a new small-batch biologics facility at the forefront of next-generation, innovative manufacturing and environmentally sustainable production

We are looking for an individual who is ready to learn, collaborate, and create solutions that will serve the expanding needs of the existing operations as well as the new biologics facility. The ability to collaborate is crucial, and success in the role will require the individual to thrive in a team environment and not act solely as an individual contributor.

This role is responsible for providing automation, instrumentation and control, and system level engineering capabilities and expertise to the Engineering Group including generating qualification protocols and maintaining the validated state of systems and processes. Focus on providing long-term support for existing facilities with respect to the automation and instrumentation and control systems for process, utility and building systems. Lead automation impacting projects with small and/or focused scope and provide input into strategic initiatives.

Responsibilities

• Perform automation and instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrade and replacement
• Produce and review design drawings and specification documents (URS, FS, DS, etc.)
• Generate, execute, and review design testing, generate and participate in functional specification testing, and perform field inspection services
• Generate, execute, and review Installation, Operational, and Performance Qualification protocols
• Generate, review, and approve GMP Lifecycle Documents (e.g. risk docs, trace matrices, periodic review, etc.)
• Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met
• Adhere to site SOPs and WIs for daily and project deliverables and provide improvements to business processes
• Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans)
• Automation lead for equipment/software FAT, field testing and commissioning

Job Requirements

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) plus 5 years’ experience, or Master’s degree in Engineering plus 4 years’ experience
• Experience with Biopharmaceutical manufacturing, design or/and construction
• Minimum of 5 years’ applicable automation and/or instrument and control system experience
• Minimum of 3 years’ GMP experience in the pharmaceutical or biotech industry
• Minimum of 4 years' experience with Emerson DeltaV Process control system (PCS) system infrastructure (required)
• Proficient knowledge of Emerson’s DeltaV, managing interfaces to external systems including OPC Servers, and associated programming languages
• Ability to generate engineering drawings and specification
• Knowledge of ISA standards, P&IDs and practices for instrumentation
• Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility

Work Environment/Physical Demands/Safety Considerations

• May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots. No make-up or jewelry can be worn when working in the clean room environment
• May work with hazardous materials and chemicals

Relocation assistance is available for this position.

The expected salary range for this position based on the primary location for this position of California is $68,000-$154,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

The Global Head of Scientific Operations and Innovation is a key scientific leader and integral member of the Translational Medicine leadership team accountable for leading a global team (50+ individuals) responsible for creation and implementation of clinical / companion diagnostic and biomarker operations strategies across all therapeutic areas, as well as for creating and implementing innovative translational and clinical technology development strategies in order to further our drug development efforts.

Reporting directly to the Head of Translational Medicine, The Global Head of Scientific Operations and Innovation requires an individual to possess a cross-enterprise (borderless) mindset with outstanding communication and leadership skills in order to enable fruitful collaboration and strategic partnerships across the Roche organizations as well as the ability to build and maintain strong relationships externally. This individual will work closely with leaders across Research, Early Clinical Development, Computational Sciences, and Development Sciences in gRED, Product Development and Global Product Strategy in our late-stage Pharma organization, as well as globally across the Roche organization (e.g., Roche Diagnostics, Foundation Medicine, etc.) in order to advance the organization's impact on programs and strategies to develop therapies that provide transformative benefit for patients.

This individual must be viewed as a strategic thought leader, partner and scientific expert, who can readily bridge cutting-edge translational medicine environments with a fast-paced clinical development organization and pipeline. They will be a key voice and scientific expert at governance committees including, but not limited to, the Research Review Committee (RRC), Development Review Committee (DRC), and late stage therapeutic area committees. As a member of the Translational Medicine Leadership team, they will help lead, shape and guide the Translational Medicine organization.

Key Duties and Responsibilities:

• Accountable for global companion diagnostic development strategy and execution across all therapeutic areas for all gRED and PD molecules including close coordination (i.e., dotted-line reporting) with pRED CDx development staff to ensure consistent CDx development approach across Pharma/REDs.
• Accountable for ensuring strategic and impactful collaborations within Roche (Roche Diagnostics, Foundation Medicine, etc.) and with external diagnostic partners (e.g., Illumina) that serve our drug development efforts
• Accountable for short and long-term planning for Clinical Oncology Biomarker Operations portfolio initiatives from strategy to execution for all biomarker plans across the gRED portfolio
• Strengthen existing and explore novel strategic partnerships, both across Roche and externally, that aim to achieve mutually beneficial results
• Accountable for strategic leadership and oversight of all Translational Medicine technology assessments, recommendations and deployments across drug development in order to impact our drug development programs, drive prioritization and benefit the portfolio
• Establish and maintain strong external partnerships with key opinion leaders, academic institutions and key external partners/organizations and be a recognized scientific thought leader in the field of Translational Medicine to advance drug development through innovative approaches
• Build and strengthen the global scientific impact of Translational Medicine Scientific Operations and Innovation on Early and Late Stage drug development programs and initiatives
• Responsible for achievement of complex and significant strategic initiatives through senior leaders at governance and alliance meetings
• Collaborate extensively and effectively with key internal senior leaders and external stakeholders to develop strong partnerships and collaborations.
• Influence corporate decisions with regard to the design and selection of New Molecular Entity (NME), ESR/LSR, IND, Early Development Go/No Go, CDP development and global regulatory approvals.
• Act as a thought leader and active participant within the Translational Medicine leadership team aware of innovative approaches and external trends / competition so that she/he can influences strategies and guide the direction of key initiatives
• Develop internal talent by creating and providing opportunities for scientific, functional and technical leadership, project responsibilities, matrix leadership and people management that meet the organizational needs both now and in the future
• Creates an inclusive and inspiring scientific environment in order to deliver a diverse and highly productive organization that can attract and retain the best talent
• Responsible for prioritizing resources to ensure optimal delivery of initiatives within budget and defined timelines

Key Qualifications, Attributes and Experience:

• Ph.D., M.D. or M.D. /Ph.D. in Biology, Molecular Biology or related field
• 15+ years of progressive experience in a science based, highly matrixed drug development organization leading companion diagnostic development, novel technology assessment and implementation and/or biomarker operational efforts
• Proven strategic and scientific leadership with background in both Oncology and Non-Oncology indications
• Proven track record of building high-performing, impactful teams and staff
• Proven track record of successful innovation as evidenced by patents, publications and products
• Excellent leadership capabilities with demonstrated skill in building, guiding and fostering productive cross-functional and cross-organizational collaborations
• Exceptional communication, influencing and collaborating skills in a matrixed environment

Relocation benefits are available for this job posting.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

• Conduct independent research under joint mentorship of Drs. Geiger-Schuller and Corrada-Bravo
• Develop novel computational methods for interpretable representation learning of multi-modal combinatorial perturbation data
• Collaborate with colleagues in neuroscience on the design and analysis of perturbation studies including the application of methods developed in this project
• Publish high-quality papers reporting on methodological and biological advances resulting from this work
• Share new methodological advances with the broader scientific community as open-source software

• Ph.D. in Computational Biology, Computer Science, Statistics, Biostatistics or related field
• Demonstrated ability to design, implement and apply modern statistical and computational methodology for the analysis of high-throughput genomics data in general (e.g., scRNA-seq, RNA-seq, scATAC-seq, ATAC-seq, CITE-seq, etc.)
• Expertise implementing statistical and computational methods in appropriate data intensive programming environments: e.g., python, R or Julia.
• Demonstrated ability to effectively communicate about complex bioinformatics problems to peers, users and leadership.
• Independent, highly motivated, and highly collaborative with the ability to work together with multi-disciplinary teams of computational scientists and biologists.

• Specific familiarity with data analysis of Perturb-seq, scRNA-seq, CITE-Seq or scATAC-seq is a plus.
• You are enthusiastic about working in a scientific environment, especially one that is related to drug discovery and development.
• You are a quick learner, are curious about new areas and the opportunity to build expertise, and courageously and creatively take initiative to see your ideas implemented.
• You are able to perform at a high level in a fast changing and demanding environment.

The Medicaid Leader is a crucial role in CMG (Commercial, Medical, Government Affairs) that applies enterprise-level mindset, people management and technical expertise working at the intersection of data, process operationalization, automation and optimization, policy, and innovation. Ensuring the Government Programs Department remains at the forefront of the industry. This leader is expected to constantly evolve and anticipate the needs and capabilities of our customers, adapting to our ever growing portfolio, operating with the highest levels of compliance and integrity, protecting our business and brand, and contributing the delivery of Genentech’s vision.

You will own the end-to-end (E2E) strategy and execution of State Medicaid operations, implementing new and updated legislation, applying account management principles, developing process improvements and organizational design so that resources are optimized.

RESPONSIBILITIES:

LEADERSHIP, INFLUENCE, STAKEHOLDER MANAGEMENT AND PARTNERING

• This position will exercise leadership across many functions in CMG as well as leadership through a group of managers to perform the Medicaid program operations and cross-functional projects, in addition to representing the Government Programs function internally.
• Co-create the vision and strategy for Government Programs department, including contribution to the development and implementation of cross functional initiatives.
• Lead and influence in a matrix environment; promote teamwork and partnering across CMG
• Key internal stakeholders that this role will be collaborating with Senior leadership across CMG, Leaders in Strategic Analytics and Insights,, Senior Directors of Government Affairs, National Account Management and team members in the Customer Engagement network, IT, Legal, Compliance, Finance including Reserves Review Committee and Internal Revenue Management
• As a member of the Medicaid Community of practice (CoP), educate and mobilize stakeholders to embrace knowledge exchange and accountability for high quality outcomes in the Medicaid space.
• Key external stakeholders that this role will be interacting with and influencing include Medicaid State Agencies, Pharmacy Benefit Administrators (PBAs) that operationalized Medicaid programs on behalf of States, National System Administrators such as Model N, and National Council for Prescription Drug Programs (NCPDP)
• Exhibits maturity, expertise to propose, design and influence industry-wide standards by participating as an active member of NCPDP and its working groups.
• Working with internal functions and external vendors to understand market trends and implications. Additionally, assess the benefits and impact of automation or implementation of digital solutions to business-critical processes which may also include recommendations on changes involving people processes and organizational structure.
• Deeply connects and understands customers and closely partner with stakeholders (internally and externally) to develop the strategic direction of the department including people, end-to-end processes, data, and technology within budget to deliver the highest value outcomes for Patients, Customers and Genentech.
• Lead, manage and mobilize agile teams including a group of contract workers. Manage the end-to-end projects ensuring the delivery of tangible and meaningful value aligned with customer needs and expected business outcomes.
• Lead process operationalization, automation, and optimization. Focussing on the use of technology to augment capabilities and efficiency.

PEOPLE MANAGEMENT:

• Build, lead and motivate your people by embodying servant leadership principles - ensuring the highest level of performance, professional and personal development as well as well-being.
• Create and foster a culture that enables and requires employees at all levels to live our Operating Principles in all aspects of their work
• Embody a player/coach mentality; be a thought partner to your team and cross functional partners.
• Fully embody and actively contribute to the advancement of the organizational DEI goals, operating by and applying the diversity, equity and inclusion lens across job responsibilities.
• Leverage Talent Flow to manage variable workload demands and Agile Ways of Working to deliver your work.
• Support longer-range departmental planning; determining resource requirements, headcount, infrastructure, systems, tools, processes, etc.

IMPACT AND COMPLEXITY

• Ensure compliance with Government laws, regulations and contractual obligations
• Ensure that State Medicaid Programs accurately reflect the Formulary Status specified for our contracted products.
• Execute Value Based Contract Agreements with State Medicaid Agencies for selected products.
• Review and Approve State Medicaid, Managed Medicaid and Supplemental invoices providing concise and relevant information for next level approvers so that there is a high confidence level on internal controls and analytics.
• This role will ensure that Genentech utilizes the industry standards, enterprise-level infrastructure (i.e. process, technology, tools, data assets) so that revenue leakage is prevented and Medicaid invoice processing and insights (retrieval, review, adjudication, disputes, resolution and reporting) solutions are performed in the most operationally and cost-efficient ways.
• Work with the Directors in Government Programs and other leaders across CCM to ensure timely and consistent communication on business and operational challenges and opportunities
• Coordinate discussions and negotiations with vendors
• Ensure Standard Operating Procedures, Work Instructions are current and Internal Controls of Financial Reporting (ICFR) are followed.
• Accountable for the Medicaid department budgeting and financial management, including the identification and transition to diverse vendors so that the department actively contributes to the Genentech’s DEI commitments.

Operating Principles:

• Put Patients First: I always act as if patients I know are in the room and do what’s best for them.
• Follow the science: I seek answers through experiments, data and debate, and act on facts.
• Act as one team: I care, collaborate and commit without boundaries, and trust others to do their part.
• Embrace differences: I seek diverse perspectives, invite opposing views, and challenge myself and others.
• Accelerate learning: I push to learn new things even if difficult, and openly share my successes and failures.
• Simplify radically: I eliminate complexity, reuse with pride, and accomplish more with less.
• Make impact now: I take accountability to do what's right, deliver value fast, and don;t wait for certainty.
• Think long term: I choose actions today that benefit future generations.

PLEASE NOTE: If you believe you meet the minimum qualifications (marked as required) to do the work we have described here, and if you are excited about the work, we encourage you to apply even if you are not sure you meet every preferred qualification (marked as preferences). We recognize that some candidates will consider applying for these roles only if in addition to the minimum qualifications, they also meet all preferred qualifications. Others will apply simply if they believe they generally fit the profile of someone in this role. We aspire to represent and meet the expectations of the communities we serve, and are eager to have a diverse pool of candidates and challenge ourselves to find new and better ways of doing the work that we do. Thank you.

What You’ll Need To Be Successful

To be successful in this role, you will need deep understanding of Managed Care and Organized customers with a keen interest in digital technologies platforms and solutions that advance patient access.

• 7+ years of leadership experience in managed care and/or related technology-centric knowledge
• Bachelors Degree Required; Advanced degree (MBA, MS) preferred
• Exhibits a Lean-Agile Mindset and excels at Product Management capabilities
• Takes calculated risk, but risk that leads to innovation opportunity and progress
• Effective communicator, someone who can inspire and energize people with ideas and proposals.
• Demonstrates an executive presence, strong business acumen, strong passion for innovation, ability to navigate ambiguity, and manages complexity.
• Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.
• Exhibits intellectual curiosity, an entrepreneurship attitude, integrity, ability to mobilize and empower teams and individuals to act autonomously holding them accountable for results.

Location: South San Francisco

There is no remote option for this position.

Relocation is not budgeted on this posting

Travel up to 15%

The expected salary range for this position based on the primary location of California is $144,500 - $268,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

The State Government Affairs (SGA) Senior Manager is responsible for working collaboratively with internal and external stakeholders across the assigned states and Genentech’s Customer Engagement (CE) field ecosystems, in a designated region of the United States, to advance Genentech’s legislative and regulatory priorities. The region will include approximately 4-6 contiguous states. It is expected that the Senior Manager will reside in the designated region. Through their work, the Senior Manager will develop relationships and influence legislative and executive policy decisions, while supporting the needs of patients and customers to advance Genentech’s business goals.

Key Responsibilities

The SGA Senior Manager’s responsibilities include:

Interactions with external stakeholders:

• • Advocating and lobbying, on the company’s behalf, with state legislatures and executive branches including, but not limited to:
    • Assisting in the development of legislative and regulatory policy positions
    • Drafting amendments, preparing and delivering testimony; and,
    • Attending and representing Genentech at legislative hearings, meetings and events.
    • Developing and sustaining strategic relationships with external stakeholders, including but not limited to: elected officials and staff, relevant state agencies and departments, industry partners, trade associations, third party stakeholder groups - including advocacy partners - and identifying opportunities for shared legislative/policy objectives.
    • Registering as a state lobbyist, completing any required training and reporting requirements, as well as managing contract lobbyists and association member engagement. The Senior Manager, like all Genentech employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities.

Engagement with internal stakeholders:

• • • Being a strategic advisor and partner to CE field ecosystem leaders and teams, as well as home office business partners, including national account managers, on interactions with external stakeholders to advance Genentech’s policy and business objectives.
    • Serving as an executional catalyst for the CE ecosystem leadership teams. The Senior Manager will develop a deep understanding of their region and ecosystems’ business priorities, needs, and regional nuances to incorporate into their own planning and execution activities.
    • Preparing briefings and/or presentations to keep internal partners, ecosystems, and other stakeholders abreast of evolving state legislation, regulations, reimbursement and Medicaid policies and executive branch decisions that may impact Genentech patients, products, or other business activities and goals.
    • Monitor and engage in Medicaid policy developments in collaboration with the State Policy Team, industry partners, trade associations and third-party advocacy organizations; support education of internal stakeholders and field partners (e.g., ecosystem leadership) to advance an understanding of Medicaid policy in conjunction with the State Policy Team, and provide support for field engagement with Medicaid agency staff on policy issues.

Core Competencies

The Senior Manager, State Government Affairs will use the following skills/competencies to advance Department, team and cross-functional business objectives and achieve results:

• • • Strategic Agility: The Senior Manager will identify timely opportunities and threats for Genentech’s full portfolio in assessing the local/state political, advocacy, policy and health care market landscape in collaboration with internal and external stakeholders, primarily within the assigned region and ecosystems. The Senior Manager will develop and manage projects effectively and efficiently, with the ability to multi-task simultaneously on competing priorities.
    • Teamwork & Collaboration: The Senior Manager will develop, evaluate and maintain relationships with internal team members and external partners, including within the Southeast regional ecosystems. They will collaborate across the team, Department and full Organization to achieve results. They will have a clear understanding of strategies and tactics required to advance an agenda while maintaining influence and credibility in a multi-stakeholder environment.
    • Achieving Results: The Senior Manager will monitor trends, identify internal and external opportunities, and support the team to drive for positive results. They will provide support leadership in setting short-term and long-term objectives and will work with team members to facilitate successful engagement with a variety of internal and external stakeholders.
    • Communication: The Senior Manager will translate complex policy and political dynamics and tailor messages to a wide variety of audiences. They will create and edit written documents and oral presentations for internal and external stakeholders. The Senior Manager will engage with internal and external individuals and groups to achieve alignment on key issues, actions and initiatives.
    • Technical & Business Expertise: The Senior Manager has a broad knowledge and understanding of state governments, legislative processes and health care related policy issues. They will assess the impact of proposed and enacted federal and state policies on Genentech’s portfolio, including the understanding of political dynamics and realities that support or pose barriers to business and ecosystem priorities

Operating Principles:

• Put Patients First: I always act as if patients I know are in the room and do what's best for them.
• Follow the science: I seek answers through experiments, data and debate, and act on facts.
• Act as one team: I care, collaborate and commit without boundaries, and trust others to do their part.
• Embrace differences: I seek diverse perspectives, invite opposing views, and challenge myself and others.
• Accelerate learning: I push to learn new things even if difficult, and openly share my successes and failures.
• Simplify radically: I eliminate complexity, reuse with pride, and accomplish more with less.
• Make impact now: I take accountability to do what's right, deliver value fast, and don't wait for certainty.
• Think long term: I choose actions today that benefit future generations.

PLEASE NOTE: If you believe you meet the minimum qualifications (marked as required) to do the work we have described here, and if you are excited about the work, we encourage you to apply even if you are not sure you meet every preferred qualification (marked as preferences). We recognize that some candidates will consider applying for these roles only if in addition to the minimum qualifications, they also meet all preferred qualifications. Others will apply simply if they believe they generally fit the profile of someone in this role. We aspire to represent and meet the expectations of the communities we serve, and are eager to have a diverse pool of candidates and challenge ourselves to find new and better ways of doing the work that we do. Thank you.

Qualifications

• • • BA/BS minimum
    • Advanced degree preferred
    • 5-7 years in legislative and executive branch advocacy experience working in state governments
    • Residency in designated region, relocation not included
    • Minimum travel anticipated 60%

This position needs residency within the region (the states covered include: Colorado, Arizona, New Mexico, Wyoming and Utah); Preferred residency is in Colorado.

Relocation benefits are not available on this posting

The expected salary range for this position based on the primary location of Colorado is $140,400 to $260,800/yr. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

In this position, you will be responsible for developing, managing, and maintaining high impact cross-portfolio prioritized and actionable managed care customer segment level strategies (e.g., the future of national payer / PBMs, evolution of private equity in the community, health system viewpoints, etc). The scope and outputs of this work will be a critical and actionable input to the work of PCD strategy managers and directors, who are responsible for developing, managing, and maintaining the pricing, contracting, and distribution strategies for Genentech’s products (in-line and / or pipeline).

This work is also a key subset of the work involved with the Future of Contracting (FoC) initiative. The Future of Contracting (FoC) is a US Leadership Team prioritized WPT that is preparing our organization for Genentech’s evolving portfolio and competitive landscape, along with the evolving needs and capabilities of our customers.

This work includes effectively leading cross-functional strategy development teams in a dynamic environment, establishing clear and effective communication across the organization, building collaborative relationships with senior leaders within Squads, GPS, Ecosystems, NCSD, NAD, SAI, Marketing, and AEA, and developing, synthesizing and communicating scenario analysis/modeling for overall strategic, financial and legal viability.

The outputs of this work have direct and meaningful impacts on Genentech’s P&L, on our ability to compete effectively, and on our ability to maintain patient access. This work requires significant relevant managed care / market access and strategy experience.

This individual also lives the CMG Operating Principles (I put the patient first always; I am tenacious in meeting customer needs; I act on behalf of the whole company, not just my own team; I am accountable; I use time and resources to create the most impact; I am inclusive; I have a bias for action; I build a culture of trust; My career will thrive as I grow my capabilities and increase my impact; I act with integrity)

Core Competencies:

The successful candidate will demonstrate the following competencies critical to this role:

• Communication & influencing: Ability to frame information accurately and concisely, appropriately tailoring communications to varying audiences, both internal and external. Ability to distill complex topics, issues, and analytical components; ability to communicate these topics to others with varying backgrounds and expertise. Ability to effectively influence others without authority
• Teamwork & Collaboration: A drive to work with peers, partners, and others, including individuals outside your own team and functional area to positively impact business performance and optimize the input of those involved.
• Strategic Agility: Ability to think beyond your own area of expertise and in a longer-term context. Ability to translate vision into a direction that adds distinct value to Genentech and builds competitive advantage. Ability to iterate and evolve strategies with agility given outcomes and / or changing conditions.
• Managing Change: Ability to accept change as positive and adapt accordingly, ensuring that changes are thoroughly and smoothly implemented, and that the lasting benefits of change are achieved.

Specifically, you will be accountable for consistently and effectively accomplishing the following:

• Explore, develop and maintain pricing and contracting strategies across multiple segments (including national and regional payers, clinics, hospitals, channel, etc).
• Identify portfolio trends and pursue knowledge gaps to strengthen pricing, contracting, and distribution strategies across brands
• Proactively identify and lead initiatives to implement new / innovative pricing and contracting opportunities for Genentech (dependent on brand / portfolio needs and / or in partnership with key external accounts); may include market research depending on the situation
• Work with US pipeline strategy teams and Global Access / global Lifecycle Teams to ensure that short- and long-term access trends and lifecycle considerations are incorporated in brand-level strategies
• Partner with and influence functional partners (e.g., Marketing, Legal, Operational teams, etc.) and senior leaders across the commercial, medical and government affairs organization to make pricing, contracting and distribution related strategy decisions for the portfolio.
• Provide strategic analytics, insights, modeling and scenario development and recommend solutions to meet Genentech's strategic, financial and operational objectives. Includes leading cross-functional teams, articulating operational complexities, operational execution, implications, requirements, impacts and the like for all recommended strategies.
• Explore, develop and maintain channel distribution strategies while balancing patient access, control, and support needs.
• Support deliverables for US Leadership Team (USLT) as needed
• Educate and share managed care knowledge across field teams, Marketing, and Squads.
• Provide strategic input / guidance on policy efforts led by External Affairs, Legal and Govt Pricing that may impact gross/net product pricing or other innovating pricing initiatives
• Stay abreast of macro trends in the healthcare environment that potentially impact current and/or future product pricing, contracting and distribution and associated strategies across Genentech’s product portfolio

Qualifications:

PLEASE NOTE: We recognize that some candidates will consider applying for these roles only if they meet all required and preferred qualifications. Others will apply simply if they believe they generally fit the profile of someone in this role. We are eager to have a diverse pool of candidates; and we are eager to be challenged to find new and better ways of doing the work that we do. If you believe you are qualified to do the work we have described here, and if you are excited about the work, we encourage you to apply even if you are not sure you meet every qualification. Thank you.

Minimum Qualifications;

• Bachelors Degree
• Minimum 3-5 years of healthcare and specifically managed care / market access strategy experience
• Strong analytical skills and financial acumen, analyzing, synthesizing and summarizing financial and qualitative data; and translating this into valuable business insights
• Strong strategic agility: understands pharmaceutical/biotechnology or related industry and the associated business models
• Proven ability & track record in communicating complex topics in an user-friendly manner and influencing others effectively without authority.
• Strong partnering skills: has effective working relationships with internal and external partners/stakeholders
• Organizational & time management skills: ability to effectively manage and complete multiple priorities and projects
• Customer orientation/focus
• Business travel, by air or car, is required for regular internal and external business meetings

Preferred Qualifications:

• Bachelors Degree in general business, healthcare, science, engineering, policy, economics, or finance disciplines
• MBA or other related Graduate-level degree with a concentration in healthcare discipline
• Account management or consulting experience

Roche is an equal opportunity employer.

South San Francisco Preferred, Remote Considered

The expected salary range for this position based on the primary location of California is $166,700 - $309,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Key Responsibilities

Contributes with in-depth knowledge of own job discipline/chapter. Has developed a variety of skills typically gained through years of professional experience. Works autonomously with minimal supervision. May lead or contribute with skills to projects/squads. May act as a coach for colleagues with less experience and provide guidance.

• Deliver 1:1 career development to employees in alignment with Genentech and Roche values
• 1:1 career coaching sessions with Individual Contributors, People Leaders
• Provide a welcoming and enthusiastic environment to new hires by facilitating New Hire Orientation
• Seeks out the knowledge about GNE and Roche resources to ensure that clients are aware of programs and services (seen as an expert)
• Work within our online scheduling database to capture client notes and records
• Creates an connections with clients based on dignity, inclusiveness and respect
• Passion for delivering quality service that exceeds expectations
• Strong communication, facilitation, instructional design and presentation skills
• Able to balance employee needs with the needs of the business
• Able to review data and draw conclusions to enhance programming
• Keeps up to date on People Experience trends for career development and new hire experience (passion for learning)
• Ability to work with internal staff to generate online career resources that support and align with Genentech and Roche operating principles and philosophies (Create and manage on demand content to support employee development)
• Comfortable flexing between roles and projects within the People Experience team as it relates to Career Development and New Hire Experience

Skills

• Certification or training or education in career development, and/or career counseling/coaching experience preferred
• Certification in various assessments, ex: MBTI, Enneagram, StrengthsFinder, Strong Interest, etc preferred.
• Quick adaptability to change
• Self-starter
• Creative thinker
• Excellent networking skills

Experience & Education

• 5+ years in the field of Human Resources, People Experience Coaching, Career Development and/or Counseling
• Certified coaching professional required and 1 year minimum of coaching
• Bachelor’s degree in related field required, Master’s degree in related field preferred

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of California is $107,660 - $199,940. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Key Responsibilities

• Deliver 1:1 career development to employees in alignment with Genentech and Roche values
• 1:1 career coaching sessions with Individual Contributors, People Leaders
• Create, facilitate and deliver intact career development and team building content to GNE teams working with directly with the client
• Goal-oriented team leader who is results-driven, proactive and has a strong work ethic
• Determines training needs for Career Lab consultants and creates training plans
• Provide a welcoming and enthusiastic environment to new hires by facilitating New Hire Orientation as a backup
• Attend Welcome to Genentech team meetings and trainings to stay up to date
• Seeks out the knowledge about GNE and Roche resources to ensure that clients are aware of programs and services (seen as an expert)
• Work within our online scheduling database to capture client notes and records
• Creates an connections with clients based on dignity, inclusiveness and respect
• Passion for delivering quality service that exceeds expectations
• Strong communication, facilitation, instructional design and presentation skills
• Able to balance employee needs with the needs of the business
• Able to review data and draw conclusions to enhance programming
• Keeps up to date on People Experience trends for career development and new hire experience (passion for learning)
• Ability to work with internal staff to generate online career resources that support and align with Genentech and Roche operating principles and philosophies (Create and manage on demand content to support employee development)
• Comfortable flexing between roles and projects within the People Experience team as it relates to Career Development and New Hire Experience
• Partner with our HR Business Partners, Talent Partners, Roche Career Center and People Experience team to develop career development strategies that support key business needs or initiatives.
• Provide leadership, mentorship and support for career development consultants in the Career Lab
• Able to incorporate Roche Operating and Leadership principles into career coaching and coach other career lab consultants
• Partner with diversity teams to integrate key concepts of equity, ally-ship, inclusion, and diversity into career development coaching
• Accountable to ensure career development training and materials are up to date
• Determine the catalog of curated content from the Roche catalog
• Collect, analyses and creates new programming based on employee’s career development needs
• Effectively prioritizes and solve complex problems while making decisions for how the Career Lab addresses the changing needs of our employees and our business

Skills

• Certification or training or education in career development, and/or career counseling/coaching experience preferred
• Certification in various assessments, ex: MBTI, Enneagram, StrengthsFinder, Strong Interest, etc.
• Quick adaptability to change
• Self-starter
• Creative thinker
• Excellent networking skills

Experience & Education

• 8+ years in the field of Human Resources, People Experience Coaching, Career Development and/or Counseling
• Certified coaching professional required and 3+ years of coaching experience
• Bachelor’s degree in related field required, Master’s degree in related field preferred

Travel

5-10% travel for intact team session facilitation

Relocation benefits are not available for this job posting

The expected salary range for this position based on the primary location of California is $135,870 - $252,330. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

This position is part of Genentech’s’ Pharma Technical - individualized and cell therapy team based in Hillsboro, Oregon. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of equipment, processes, and the quality approach for this exciting and novel technology.

Purpose:

• Responsible to ensure commercial and clinical (IMP) products fulfill the specified requirements and they are released in legal compliance with the customer markets, regulatory filings as well Roche quality requirements.
• Review and approve procedures, master batch records, and other QA controlled documentation, and associated change control.

Key Responsibilities:

• Responsible for lot disposition and release of commercial and clinical products according to the approved registration dossiers, ensuring internal standards are achieved and in compliance with local and international laws (e.g., Qualified Person/ Responsible Person).
• Create or revise quality documents. Provide Quality oversight for processes and procedures related to operations.
• Support and lead cross-functional projects and Quality initiatives. Identify and participate in the resolution of Quality risks and issues by fostering effective interdepartmental and cross-functional relations.
• Assess and resolve deviations to assure timely resolution. Partner with functional areas to resolve product quality impacting investigations and own CAPA related to area of responsibility.
• Meet budget and goals for the QA Operations function.
• Engage in proactive measures to promote a positive safety culture while meeting all applicable Safety, Health and Environment requirements in alignment with corporate policy and local legal requirements.
• Embody PT lean principles and methods while fostering a continuous improvement mindset.

Technical and Functional:

• Assure the efficient, timely, batch record review and GMP compliant product release according to schedule.
• Provide Quality Assurance oversight throughout the end-to-end production operations including Chain of Custody and Chain of Identity, assuring current GMP compliance.
• Keep current in training on cGMP, applicable regulations, and technical aspects of iNeST processes, and all areas related to core job responsibilities.
• Participate and support internal and external audits. Serve as Subject Matter Expert to defend lot disposition practices, batch records, and reports Review and approve QA documentation to ensure GMP compliance to all relevant regulations. Ensure documentation supports a continuously compliant state at HIT and a continual state of readiness for their areas of responsibility for agency inspections.
• Responsible for monitoring and continuous improvement for relevant Quality key performance indicators
• Management of deviations & CAPA, ensuring robust, thorough and complete investigations (including root cause analysis, product quality impact, interim/mitigating/long term actions and documentation). Provide the appropriate oversight and support the implementation of the actions through appropriate records, timely resolution, action and closure of the quality system records, and their effectiveness.
• Assist in building a process for complaint management execution, including oversight of complaint intake, timely evaluation, trending and issue escalation.

Key Interfaces:

• Manufacturing, all Site functions, PTD, Affiliate Quality Assurance Management, Regulatory (PTR)
• Global Quality System and Quality Management, External Quality, Supplier Quality, partners, key suppliers and CMO

Qualifications:

• Bachelor's Degree (Pharmacy, Pharmaceutical, bioengineering, Chemistry or other relevant area preferred)
• 4 or more years work experience in the pharmaceutical or related life science industry
• A minimum of at least 4 years of experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience
• Expert knowledge of Quality Assurance principles, practices and standards for the biopharmaceutical industry
• Expert knowledge of GMP relevant to the pharmaceutical industry; knowledge of the local and international GMP regulations. Knowledge of regulations related to ATMP is desireable.
• Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential
• Demonstrate excellent problem solving skills, tactical strategy, and diplomacy

Preferred Skills:

• Experience with Individualized Medicine (ATMP)
• Familiarity with computer systems and ability to quickly become familiar with new software (e.g., EDMS, LIMS, SAP) is highly desirable

Relocation benefits are not available for this posting.

#ptcareers

#cellandgenetherapycareers#

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

The role of Hospitality is to deliver value-added operations, programs, and services that are laser-focused on enhancing the daily experience of our workforce and guests.

The Hospitality Ambassador is a position within Site Services that will play an essential role in this mission by serving as the first point of contact in our lobbies, and delivering a consistently exceptional and exceptionally consistent service experience reflective of our role as the world’s leading biotechnology company.

With the sensitive nature of our work, this position will work closely with Security colleagues in our fundamental responsibility of protecting our people, products, and pipeline by ensuring safe, appropriate, and authorized access to our campus. This position requires an individual with impeccable integrity and the ability to handle sensitive and confidential information with outstanding judgment.

It also requires interacting with employees and visitors from around the world, including executives, VIPs, and regulatory agencies, as well as multiple internal stakeholders, such as our Workforce Service colleagues, Legal & Healthcare Compliance, Corporate Relations, the Genentech Admin community, Events, Site Operations, and other functions within Site Services.

These key responsibilities, and the unique opportunity this role has to impact our 12,000+ employees, contractors, consultants, partners, and visitors on a daily basis, will require exceptional judgment and discretion, as well as a genuine “heart for service”.

The Hospitality Ambassador will report to a Hospitality Supervisor.

Key Job Duties & Responsibilities:

• Deliver a consistently exceptional and exceptionally consistent Hospitality experience that delights the GNE workforce and visitors, and reinforces we care about serving their unmet needs. Serve as Genentech cultural ambassadors and the single point of contact for our lobbies, which are intended to serve as hubs for information, philanthropy, and community. Champion change to help the Hospitality team reach new heights.
• Handle all guest and employee interactions with the highest level of professionalism and hospitality mindset to ensure we are always exceeding expectations. This includes but is not limited to: processing vendor deliveries, personal items, catering and accommodating special requests whenever possible. In addition, it is expected that Ambassadors will resolve all customer inquiries, issues, or concerns promptly and graciously.
• Maintain a close partnership and strong communication with Security colleagues to ensure we are protecting our people, products, and pipeline. Ensure all outlined security processes are followed, with all guests properly signed into the Visitor Management System, security badges assigned as needed, and prompt notification to employee hosts of arriving visitors, candidates, and other guests.
• Provide excellent customer service over the phone to support our corporate call center as needed.
• Oversee and execute day-to-day partner and Hospitality programs, such as parking placards, clipper cards, transportation, and amenity services. Become a subject matter expert in assigned lobby or lobbies, as an Ambassador (particularly those assigned as Rovers) may be asked to support and/or provide backup coverage for any lobby on campus.
• Actively participate in team committees to enhance current Hospitality programs and processes and recommend improvements.
• Consistently follow all brand guidelines as outlined by Hospitality leadership, including willingness to wear branded apparel and adhere to a more professional dress code than that required of our GNE colleagues, much the same way our scientist and manufacturing roles have their own set of enhanced clothing requirements.
• Assist Hospitality Supervisor(s) with various projects as assigned.

Key Competencies Identified for Success:

The ideal candidate will have a strong hospitality background and a demonstrated “heart for service,” share a passion for teamwork and collaboration, and have a solution-oriented mindset dedicated to the continual improvement of our service experience.

Additionally, they will demonstrate the ability to:

• Display full knowledge of the job, becoming a subject matter expert with the additional ability to communicate and share that expertise with our workforce and guests. Display a general knowledge of multiple related functions, to help build strong relationships with key stakeholders, partners, and customers, and serve as advocates for their feedback and ideas.
• Embody a continuous improvement mindset by:
• Making valuable recommendations towards developing and improving operating policies and procedures to ensure and increase the quality, precision, and timeliness of our service delivery.
• Embracing new technologies, workflows, and other process improvements, particularly when related to the safety, productivity, and convenience of our workforce and guests.
• Being receptive to feedback and suggestions from our teammates, workforce, guests, and open to coaching and development from supervisors, managers and mentors.
• Act as a self-starter and work under limited supervision, with the sound decision-making abilities and business judgment to make decisions within established policies and procedures, and in some cases, even serve as a team lead on projects or committees, but also take direction and follow verbal and written instructions when required.
• Be adaptable and flexible to changing business priorities, particularly in an increasingly agile, iterative environment. Effectively prioritize multiple priorities, including in the face of other distractions, while maintaining an impeccably gracious demeanor and focus.
• Maintain a solution-oriented mindset, with solid analytical and problem-solving skills, attempting to use available resources to problem-solve when encountering challenges or roadblocks, and constantly looking for opportunities to anticipate needs and problems, then exceed expectations.
• Possess exceptional communication and interpersonal skills, and demonstrate a warm, gracious, and professional demeanor in all interactions, which includes treating our teammates and colleagues with the identical level of consideration and respect as our guests and visitors.
• Foster a spirit of generosity and an attitude of gratitude within our team, as well as the larger GNE community, and be aligned with our core values of service and philanthropy.

Key Qualifications

• High School diploma required, and either 5 – 6 years of relevant corporate hospitality work experience in a fast-paced environment with exceptionally high standards, or commensurate high-touch, white-glove customer service experience in another industry (e.g., high-end hotel or retail).
• Advanced proficiency with common business software applications such as MS Office Suite and the Google Suite of tools (e.g., gMail, gCal), as well as the ability to quickly master other more complex, business-specific technology tools (e.g. cloud-based visitor and call center management software)
• Demonstrated ability to operate standard office equipment (telephone systems, copiers, scanners, printers, fax machines).

This position is not eligible for relocation.

The expected salary range for this position based on the primary location of California is $55,000 - $102,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

We are seeking a creative, enthusiastic, and highly motivated cell culture and molecular biologist to join our mammalian cell line development group. The successful candidate will primarily be responsible for rAAV stable cell line generation with special emphasis on achieving high rAAV titers with good product quality. This candidate will also be expected to perform commercial stable cell line generation for antibodies, bispecific antibodies, Fc-fusions, antibody fragments and other complex biologic molecules for the clinical and commercial manufacturing of therapies in Genentech’s pipeline.

This is an ideal position for a researcher who is enthusiastic about research, innovation, and drug development experience in gene therapy and large molecule biologics. As such, the position requires excellent communication skills and the desire to continuously learn more about the gene therapy and drug development process. The successful applicant will work independently with minimal supervision and will be primarily responsible for the design, creation, sequence verification, quality control and documentation of DNA plasmids and stable rAAV cell line generation.

Qualifications

Required:

• Ph.D. (0-3 years of experience) or M.S. (5+ years of experience) or B.S. (10+ years of experience)
• Relevant cell culture and molecular biology experience
• rAAV production experience
• Exceptional oral and written communication skills

Desired:

• Relevant rAAV production and stable rAAV cell line development experience
• Relevant experience with contemporary molecular biology techniques
• ddPCR & qPCR experience
• Relevant rAAV purification experience
• Relevant rAAV characterization experience

Please note:

The expected salary range for this position based on the primary location of South San Francisco, CA is $95,400 to $177,200.00. Annual Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are available for this job posting.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

We are seeking a highly motivated Postdoctoral Fellow to join the Microchemistry, Proteomics & Lipidomics (MPL) department. The successful candidate will develop a native mass spectrometry based platform for high-throughput lipid transporter and receptor ligand binding and signaling. In addition, the achievement of high-resolution structures will enable elucidation of signaling and transport mechanisms of human membrane targets. You will perform a range of experimental methods, including protein production, biochemical assays, native mass spectrometry and high-resolution structural analyses.

Who you are:

Requirements:

• A PhD in Chemistry, Cell Biology, Bioinformatics, Biochemistry, Cancer Immunology, or a related discipline
• One or more first author research publications (or in press) in high quality journals
• Experience with native mass spectrometry and other structural enabling technologies
• Hands-on experience cloning, engineering and optimizing the production of protein targets for functional and/or structural studies

Additional Desired Qualifications:

• Excellent communication, interpersonal and organizational skills
• An understanding of membrane protein biochemistry is a plus
• Proficiency in structure determination using X-ray crystallography and/or cryo-EM is desired

For information about the Postdoctoral Program at Genentech, please go to:

https://www.gene.com/careers/university-and-early-career/postdocs

The expected salary range for this position based on the primary location of California is $64,800 and $120,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are available for this job posting.

#postdoc

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

This position is part of the consolidated analytical development team responsible for supporting the development of new modalities in the newly created Pharma Technical Cell and Gene Therapy (PTC) organization, the position is based in Hillsboro, Oregon. PTC focuses on the development of cell and gene therapies for the treatment or cure of various diseases. In this role, you will lead the Analytical Development and Testing (ADT) Operations Team in support of the clinical development of iNeST RNA/DNA vaccines and cell therapies.

The Operations Team Leader, ADT is responsible for creating a culture of excellence in the analytical testing areas. They are responsible for managing staff, and ensuring high engagement in employees with a focus on diversity, inclusion and development. Focus areas in this job will be excellent lab operations, customer service, and the quality control management aspects of the department. As the leader of the Operations Team, you will define the requirements for QC operations and establish processes to ensure production consistency and product quality. This role requires close partnership with Manufacturing, MSAT, global teams and Quality to achieve speedy clinical proof of concept and readiness for commercial GMP production.

Responsibilities:

Leadership and People Management

• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term
• Establish goals and objectives and maintain full tactical responsibility for the operations team
• Drive collaboration within the site, cross-functional planning and decision-making.
• Proactively promote positive safety culture and cGMP operating principles.
• Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by practicing experimentation and learning

General Management

• Ensure SHE and cGMP compliance
• Partner with and support Quality functions
• Provide support and engagement on tech transfer and development projects
• Oversee laboratory operations, including testing activities, equipment maintenance, reagent preparation, data review and reporting, and deviation management
• Establish SOPs, specifications, and testing methods in full compliance with cGMP regulations and evolving expectations
• Lead root cause analysis (RCA) following the principle of investigating to the best of our capabilities, and subsequent implementation of corrective and preventive actions (CAPA)
• Develop new business processes to constantly improve ourselves
• Support regulatory inspections and partner audits
• Ensure appropriate training is assigned to team members performing GMP activities
• Review and approve SOPs, protocols and reports
• Perform technical review and/or approval of data and assess against established acceptance criteria
• Own discrepancies and provide input to the design of quality investigations and CAPA initiatives as needed
• Close gaps, solve technical problems, manage troubleshooting
• Establish team priorities to meet targets and timelines; manage competing priorities
• Serve as an ADT representative on cross-functional and multi-site teams
• Serve as a technical subject matter expert (SME) in support of department functions
• Perform any other tasks as requested by Management to support analytical activities

This position may be hired as a Senior Supervisor/Manager, depending on the candidate's qualifications/experience.

Senior Supervisor Qualifications/Requirements:

• Bachelor's degree and five years of experience or Master’s degree plus three years of experience or an equivalent combination of education and experience. Degrees are preferably in Chemistry, Biochemistry, Molecular Biology or relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry
• Experience in cGMP laboratory operations, planning and designing Quality Control processes
• Advanced knowledge of cGMPs relevant to the pharmaceutical industry
• Professional level written and oral communication skills, ability to organize and present information and to influence at all levels
• Experience using and maintaining lab systems (e.g. LIMS, CDS, LES)
• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical method development, qualification/validation, and implementation
• Ability and willingness to take risks and make difficult decisions under ambiguity in order to deliver strong business results and achieve high productivity
• Strong analytical intuition, troubleshooting skills (e.g., analytical instrumentation), and problem-solving capabilities.
• Work in an office and laboratory environment
• Flexibility in problem solving, providing direction and work hours to meet business objectives
• Ability to sit, stand and move within work space for extended periods and lift up to 25 lbs
• May be required to sit at a computer terminal or laboratory bench for extended periods
• Ability to travel to other sites, as required

Manager Qualifications/Requirements:

• Bachelor's degree and eight years of experience or Master’s degree plus six years of experience or an equivalent combination of education and experience. Degrees are preferably in Chemistry, Biochemistry, Molecular Biology or relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry
• Three to four years of experience in a supervisory role
• Experience leading/managing cGMP laboratory operations, planning and designing Quality Control processes
• Expert knowledge of cGMPs relevant to the pharmaceutical industry
• Professional level written and oral communication skills, ability to organize and present information and to influence at all levels
• Experience using and maintaining lab systems (e.g. LIMS, CDS, LES)
• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical method development, qualification/validation, and implementation
• Ability and willingness to take risks and make difficult decisions under ambiguity in order to deliver strong business results and achieve high productivity
• Strong analytical intuition, troubleshooting skills (e.g., analytical instrumentation), and problem-solving capabilities.
• Work in an office and laboratory environment
• Flexibility in problem solving, providing direction and work hours to meet business objectives
• Ability to sit, stand and move within work space for extended periods and lift up to 25 lbs
• May be required to sit at a computer terminal or laboratory bench for extended periods
• Ability to travel to other sites, as required

Relocation benefits have been approved for this posting.

#ptcareers

#cellandgenetherapycareers#

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.