Longevity Industry Jobs

The Senior Quality Control (QC) Data Reviewer, reporting to the Director of Quality Control at the East Norriton, PA site, will ensure the quality of laboratory data and reports. He/she will perform accurate and timely technical review of QC data, ensuring compliance to cGMPs and to Resilience Standard Operating Procedures (SOPs), while meeting clients’ deliverables.

The Senior QC Data Reviewer will review a variety of data including, but not limited to, flow cytometry, qPCR and ddPCR data. He/she will utilize technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvements, and assist in resolving laboratory investigations as needed.

In addition to the Quality Control testing teams, the Senior QC Data Reviewer will also collaborate with QC Record Investigators and Quality Assurance specialists to ensure timely completion of deliverables.

• Flexibility to work weekends as needed**

Job Responsibilities:

Your responsibilities will include, but are not limited to:

• Perform QC technical, scientific and compliance review of data and documentation generated by the Quality Control laboratories to enable Certificate of Analysis (CoA) generation.
• Closely work with QC analysts, QC leadership and QA to perform expedited data review and communicate in-process results to Manufacturing.
• Lead/coordinate assigned functional sub-teams; participate in function-specific teams and fulfil assigned project tasks and responsibilities under minimal supervision.
• Participate in data integrity initiatives representing QC.
• Identify and drive operational excellence and continuous improvement opportunities.
• Complete all required job specific cGMP, Data Integrity, and EHS trainings and adhere/comply to appropriate standards defined for quality, ethics, health, safety, environment, and information security.
• Understand the requirements, expectations and needs of internal and external customers and interact in courteous, professional, supportive, and collaborative manner.

Minimum Qualifications:

• Bachelor of Science degree in Biology, Biochemistry, Molecular Biology or other relevant fields, A combination of relevant education and experience will be considered in lieu of degree.
• Significant experience in a laboratory setting
• Knowledge and experience with cGMP Quality Systems.

Preferred Qualifications:

• Working understanding of flow cytometry, PCR and ELISA assays
• Experience with Laboratory Information Management System (LIMS) and electronic laboratory notebook (ELN)

Other Ideal Personal Characteristics:

• Demonstrated ability to take ownership, initiative, and self-accountability
• Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting
• Attention to detail and quick learning/application of concepts and information

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $105,000.00 - $135,000.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

The Quality Specialist will organize and execute aspects of GMP implementation at the East Norriton manufacturing facility. The successful candidate will understand cGMP, explicitly building and maintaining quality systems in support of sterile/gene therapy/cell therapy manufacturing.

Job Responsibilities

• Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program.
• Build strong relationships and collaborate closely with CMC/Operations/Development teams and other relevant groups to ensure the manufacturing and testing operations will comply with all US and International regulatory expectations.
• Maintain a presence of Quality Assurance on the manufacturing floor during GMP runs to ensure compliance to GMPs.
• Escalate any events occurring on the manufacturing floor to Management.
• Review deviations, change controls, and/or CAPAs, as needed.
• Review batches manufactured at the East Norriton facility, as needed.
• Author and review technical documents, including but not limited to SOPs, and various quality reports.
• Perform Facility changeovers and Line clearances.
• Issuance of product labels, as needed.
• Release of GMP materials utilized in the manufacturing process as needed.

Preferred Experience, Education & Qualifications

• B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
• Familiarity with electronic quality systems/software applications.
• Familiarity with laboratory and manufacturing execution systems.
• Working knowledge of GLP/GCP and GxP Regulatory requirements.
• Experience in preparation and participation in regulatory authority plant/site inspections.
• Experience supporting biologics manufacturing.
• Excellent oral and written communication skills.

Minimum Qualifications

• 2-4 years of relevant life sciences quality experience within quality and/or quality-related functions.
• Demonstrated track record with the successful support of GMP manufacturing and testing environments.
• Demonstrated quality experience and the ability to collaborate with and effectively influence others.
• Demonstrate experience with gowning and following aseptic behaviors.
• Experience with aseptic, cell therapy, and/or viral vector manufacturing.

Other Ideal Personal Characteristics

• Comfortable in a fast-paced, collaborative company environment, working with minimal direction and able to adjust workload based upon changing priorities.
• Performs with Integrity.
• Ability to collaborate and manage conflict in a fast-paced environment, working across functions.
• Experience in the application of lean methodologies and operational excellence to continuously improve.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $65,000.00 - $82,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

This QA Lead Investigator role is accountable for supporting the quality management system and requirements for Deviations, CAPAs, Change Controls, Lab Investigations, etc. This role serves as the quality approver for minor and major records, author of critical records, and assures the QMS and method lifecycle is compliant, well-organized, effective, and phase appropriate. This role is the technical lead within Quality Operations in support of activities of Quality Control, Manufacturing, Engineering, and Supply Chain. This role takes the lead for many of the responsibilities listed below and represents the quality organization and department in client-facing activities at a tactical and strategic level. This role reports to the Head of Quality Operations. The position is located at the Alachua site and requires an onsite presence.

Job Responsibilities

• Independently supports as a quality approver in the Quality Management System for Change Controls, Deviations, Lab Investigations, OOSs, CAPAs, and Risk Assessments.
• Works with initiators, investigators, and stakeholders to ensure change controls and investigations are initiated, performed, and closed within the required timelines.
• Reviews CAPA investigation reports to assess the appropriateness of the identified corrective and preventive action(s) and CAPA effectiveness.
• Provides support in the preparation for, the conduct of, and follow-up activities associated with regulatory inspections, internal audits, and client audits
• Sterile gowning required to perform activities on the manufacturing floor including, but not limited to critical process observations, investigation support, and routine GEMBA walks.
• Ensures quality activities are carried out according to regulatory and quality requirements.
• Participate in applicable network communities of practices and share best practices across the network as well as lead and/or support site and network initiatives.
• Client interactions – QMS record and Change Control Notification to Clients, joint working sessions on investigations and technology transfers, and other client-facing responsibilities.
• Review & approval of product & process-related change controls (including Supplier Change notifications) and production documentation.

Preferred Experience & Qualifications

• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
• Track record of driving a quality mindset with stakeholder groups and establishing expectations and processes to maintain a standard of quality assurance and compliance.
• Formal training and experience as a trainer, author, and approver for root cause analysis, problem-solving techniques, and technical writing
• Experience with supporting regulatory inspections
• Excellent oral and written communication skills with strong technical writing experience
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
• Data and metric driven
• Knowledge of manufacturing and testing processes for biologics, vaccines, cell or gene therapy products
• Ability to communicate requirements to stakeholders and navigate the site tier structure for escalation of obstacles for resolution
• Continuous improvement mindset
• Proven record leading cross-functional teams in issue resolution and continuous improvement
• Experience with delivering presentations, facilitating, and teaching to diverse audiences
• Desire and interest to leverage new technology and innovative learning techniques
• Formal training and experience as a trainer in root cause analysis, problem-solving techniques, and technical writing
• Knowledge of phase-appropriate quality systems and product lifecycle requirements

Minimum Qualifications

• Bachelor’s degree or higher in Life Sciences discipline
• 5 - 7 years of pharmaceutical or biopharmaceutical industry experience with 3 years in Quality Control, Quality Systems, or Quality Assurance role
• Hands-on experience with the management of Quality System Processes such as Change Control, Deviation, and CAPA
• In-depth knowledge of Good Manufacturing Practices (CGMP), Quality Management Systems, and applicable industry regulatory requirements
• Experience and knowledge of cGMP and applicable FDA/EMA regulations in the biotechnology/pharmaceutical industry

Physical Requirements: (rows or statements that are not required to perform the duties of the position)

This job requires the employee to perform the following physical activities:

• Climbing
• Balancing
• Fingering
• Stooping
• Kneeling
• Repetitive motion
• Crouching
• Crawling
• Feeling
• Reaching
• Standing
• Grasping
• Walking
• Pushing
• Hearing
• Pulling
• Lifting
• Talking

This job requires the employee to work in the following conditions:

• Temperature changes
• Activities occur inside and outside

This job requires exposure to the following:

• Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
• Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
• Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
• Narrow aisles or passageways.

This job requires the employee to perform the following type of physical work:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

This job requires the following visual acuity requirements:

• preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
• determines the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $85,000.00 - $107,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

The Lead Analyst, Quality Control will partner and collaborate with the Analytical Development and QC operations teams to ensure that all required method transfers, qualifications and validations are performed, meeting all partner needs in compliance with standard operating procedures and testing methods. Specific activities include authoring/executing/review of study design, protocols and reports associated with qualification/validation/transfer studies.

This position is a first shift role and reports to the Head of QC, Method Lifecycle and Stability. The position will be in our Alachua, FL facility.

Job Responsibilities:

• Lead Analyst, Method Lifecycle activities to include, supporting method selection and development to leading method transfer, qualification and validation, monitoring routine use, leading change controls and retirement of the method
• Transfer/qualification/validation activities using protein-based assays, molecular methods, and cellular assays
• Author and/or review method transfer, qualification and validation protocols and reports.
• Assist in managing qualification/validation scheduling to ensure commitment to timelines
• Collaborate with Analytical Development personnel to ensure methods are suitable for transfer to QC for transfer/qualification/validation.
• Assists in developing, troubleshooting, optimizing complex biological QC procedures according to regulatory requirements.
• Collaborate with QC Product Testing personnel to ensure analysts are trained on newly transferred/qualified/validated procedures.
• Provide qualification/validation guidance to development and QC teams
• Analyze, document, and report experimental data in accordance to Resilience requirements
• Collect/evaluate data trends to ensure qualified/validated methods remain in a state of control.
• Represent QC MLS in client facing meetings
• May require occasional early morning, late evening, and / or weekend work.
• Provide support to the QC Operations team as needed
• Performing immunoassays, cell-based assays, molecular biology assays and virology testing in support of product release, in-process testing and stability
• Train analysts on analytical techniques
• Troubleshoot assay failures
• May require occasional early morning, late evening, and / or weekend work
• Other activities as assigned

Minimum Qualifications:

• Master's Degree with 10 years of related experience; Bachelor's Degree with 12 years of related experience
• Knowledge of Analytical Method Lifecycle requirements with previous experience in method transfer, qualification and validation.
• Experience with cGMPs applicable to the pharmaceutical industry.
• Experience with Cell based/bioassays

Preferred Qualifications:

• Proficiency in ELISA type assays (colorimetric, fluorometric, chemiluminescent, etc.) and/or qPCR and ddPCR molecular assays; virology methods such as TCID50, plaque, FFU. Experience with Capillary Electrophoresis a plus.
• Experience with data analysis software (SoftMaxPro, PLA or similar, etc).
• Strong analytical problem-solving and troubleshooting skills.
• Adaptable and flexible in response to a dynamic operating environment
• Strong verbal / written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued.

Physical Requirements:

This job requires the employee to perform the following physical activities:

• Balancing
• Use of fingers
• Stooping
• Kneeling
• Repetitive motion
• Crouching
• Feeling
• Reaching
• Standing
• Grasping
• Walking
• Pushing
• Hearing
• Pulling
• Lifting
• Talking

This job requires exposure to the following:

• Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
• Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 3, including for emergency response.
• Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.

This job requires the employee to perform the following type of physical work:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
• Medium work. Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects

This job requires the following visual acuity requirements:

• Preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.

This job requires routine or periodic use of respiratory protection:

• Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR).

EOE STATEMENT

National Resilience Inc. is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law. EEO Minorities/Women/Disabled/Veterans

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $121,000.00 - $153,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

The Process Engineer will work in the MSAT group to provide technical support to operations at the Philadelphia, PA site, for both vector and cell and gene therapy production. This position will have a focus on the digital systems used in Manufacturing, supporting the transition from Process Development during technology transfer. This role will represent Manufacturing while working with Quality and Digital to implement the automation strategy for the Manufacturing Execution System (MES) and other system integrations to MES. The process Engineering will facilitate initial build of new workflows, as well as support change, continuous improvement, validation, operation, and maintenance of the site’s MES. As the MES subject matter expert, this Process Engineer will help clients better understand the system capabilities and development requirements, providing regular updates to ensure that project deliverables are being met according to schedule. This role will also facilitate electronic batch records (EBR) report development, determining client requirements and conveying what the system is capable of generating. The Process Engineer will collaborate with peers across departments to ensure completion of projects.

Job Responsibilities

MSAT Team Member

• Provide technical support to GMP operations in a multi-product and multi-modality facility including both cell and gene therapies.
• Generate technical documents (memos, protocols, reports, plans, etc.,) related to technology transfer, process monitoring, process improvements, etc.
• Actively participate in client meetings and serve as a technical SME.
• Complete process monitoring tasks that require a variety of statistical and data analysis methods and techniques (e.g., excel, JMP, etc.).
• Be a technical resource in the evaluation and implementation of process improvements, policy changes, compliance improvements and optimization programs.
• Provide technical leadership for execution of engineering runs during technology transfer from development to manufacturing.
• Monitor, track, evaluate, and report data from unit operations to support project/client communication and deliverables.
• Develop scientific and technical understanding of unit operations and production processes.

Technology Transfer to GMP Production

• Perform key project deliverables for technology transfer activities for new client projects.
• Define and justify critical and key process parameters.
• Participate in the development of specifications, standard operating procedures, work instructions and forms to support implementation of new processes.
• Collaborate with Manufacturing as well as all support functions such as engineering, quality, and supply chain to provide robust and coordinated support.
• Train production staff to ensure they can perform duties involving new equipment and new processes.
• Generate protocols and reports for pilot, engineering, and clinical GMP runs.
• Prepare change controls and perform change control assessments according to internal procedures as required.
• Comply with safety requirements and work to resolve any environmental, health and safety issues.

MES Lead

• Support MES development by leading the initial transition from paper to digital workflows.
• Provide Subject Matter Expert support to projects for process design and operation of MES functionality.
• Coordinate with Process Development, Manufacturing, Digital and Quality to ensure the successful implementation and management of MES changes at site.
• Convert manufacturing business requirements into functional electronic workflows.
• Steward MES master data including Material Master, Bill of Materials, Configurations, Electronic Batch Record (EBR), Worksheets, Bill of Testing and Bill of Equipment.
• Support system testing and validation for Manufacturing with Digital and Quality departments.
• Train manufacturing users on MES use.

Minimum Qualifications:

• M.S./B.S. in Life Sciences, Chemical or Biological Engineering, or related discipline.
• 2-5 years of relevant industry experience in process development, technology transfer, automation, or GMP Manufacturing, preferably Cell and Gene Therapy.
• Working knowledge of current Good Manufacturing Practice and Good Automation Manufacturing Practices including Computer System Validation.
• Fluency in supporting the digitization of manufacturing & engineering business processes.
• Experience with MES administration and/or implementation

Preferred Qualifications

• POMSnet Aquila
• Experience developing acceptance criteria for technology transfer
• Experience with single use technology and systems.
• Experience working for or with contract manufacturing organizations.
• Project management and change management associated with GxP Digital Systems, with experience owning, managing, and executing change controls and using management systems (ex. Veeva).
• Coding knowledge (C#, SQL, database management) is a plus

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $77,000.00 - $98,000.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

The incumbent will provide strategic level leadership to the site location and will be responsible for Manufacturing (USP/DSP/FF, Manufacturing compliance and documentation, Training and Continuous improvement) and will support Production Planning, Purchasing and Logistics. This key role will provide oversight to Resilience Biotechnologies Inc’s site manufacturing in order to maintain strategic company goals.

MAJOR RESPONSIBILITIES:

• Provide oversight to Manufacturing teams, and support Planning and Logistics to enhance engagement of our clients, ensure the manufacturing delivery plan is such to maximise delivery success in the most efficient manner, and provide the clients with a positive experience.
• Develop the capability and the organizational structure to meet the delivery needs of the strategic business plan.
• Recruit, integrate, and retain managers and supervisors. Empower and coach the management team to develop their teams to meet the short-term delivery goals, and the longer-term strategic demands of the business plan.
• Responsible for developing, implementing and delivering continuous improvement across all manufacturing functions to increase efficiency through reduced cost, minimizing waste, increased workforce utilization and enhanced capacity.
• Utilizing appropriate Key Performance Indicators, demonstrate operational performance in terms of cost, plan adherence, improvement in manufacturing failure rate, Quality and EH&S compliance.
• Manage departmental costs and investments (people, training, plan and support tools) to meet the business needs in the delivery plan and establish the foundation for the future business development plans.
• Work closely with Facilities and Engineering team to develop and track future CAPEX plans to ensure quality execution and timely completion.
• Ensure effective management of relationships by promoting active collaboration with support groups such as Facilities, Engineering, Drug Development, Quality and Project Management.
• Collaborate with the Resilience network to find synergies in processes and improvement initiatives.
• Represent and lead Manufacturing in front of regulatory agencies (FDA, Health Canada, and EU) and client audits.
• Provide timely updates to the site Senior Leadership Team.
• Develop a robust training program/strategy
• Must stay current with relevant technologies and forward thinking to identify new approaches
• Performs all other job-related duties as assigned

MINIMUM QUALIFICATIONS:

TECHNICAL KNOWLEDGE / EXPERIENCE:

• Degree in Engineering, Science, Pharmaceutical Science or combined experience
• A minimum of 15 years of related and functional experience; preferably in the pharmaceutical / biopharmaceutical industry
• Experience in leading teams with 100+ FTE (including managers and supervisors).
• Good knowledge of Canadian, US and European current Good Manufacturing Procedures
• Grasp of business practice and how a functional department best contributes to overall business success

PREFERRED QUALIFICATIONS:

• Experience in top-tier pharmaceutical / biopharmaceutical environment
• Knowledge of regulatory agencies HC, FDA and others.

BEHAVIOURAL:

Demonstrated ability to apply the following behavioural competencies on the job:

Teamwork: Achieving extraordinary business results through people. Lead by example.

Flexibility: Agility in adapting to change, shifting priorities and driving results

Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types

Organization and Planning: Detail oriented, sense of urgency and accountability

Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective

Leadership: Achieving extraordinary operational results through inspiring, encouraging and developing people

This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.

While we appreciate your interest in this opportunity, only qualified candidates will be contacted. Resilience Biotechnologies Inc. (RESILIENCE), will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), Human Resources team.

NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target annualized base pay hiring range for this position is $170,000.00 - $237,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

• This position will perform and lead production related activities during four 10 hour shifts (0730-1730) in the cGMP Manufacturing Core according to established procedures at the Medical Counter Measures (MCMs) Advanced Development and Manufacturing Facility in Alachua (Florida).
• Lead downstream related activities including chromatography purification, centrifugation and ultracentrifugation, ultrafiltration/diafiltration, and viral clearance.

Job Responsibilities

• Draft Standard Operation Procedures, Change Controls, and Events, and Deviations.
• Properly disinfect and stage materials into production rooms before the production campaigns.
• Order equipment and perform installation, qualification, and routine maintenance.
• Draft and review Production batch records and review executed records.
• Write raw material specifications. Research, source, and order material and lab wares.
• Lead change-over cleaning in the manufacturing core and other production areas.
• Lead activities to support production campaign such as preparation of tubing assemblies, autoclaving, material request, and material transfer into production rooms.
• Approve timecards, personal time off requests, and coordinate scheduling of direct reports for on-time delivery of manufactured products.
• Conduct mid-year and end of year employee reviews for direct reports.
• Create and guide direct reports using Performance Improvement Plans, if necessary.
• Participate in hiring panels.
• Adhere to safe working practices.
• Provide other assistance as needed to the Manufacturing Managers

Preferred Experience, Education & Qualifications

• Minimum of a high school diploma or GED and 6 years of relevant work experience. A post-secondary degree from an accredited institution with a major field of study in Biology, Chemistry, Engineering or similar may substitute for the required experience (for example, an A.S and 4 years of experience, B.S. and 2 years of experience, M.S. and 1 years of experience).
• 2 years of team leadership responsibilities preferably in a cGMP environment.
• Ability to document work clearly and accurately and be detail oriented.
• Must have basic computer skills and familiar with Word and Excel.
• English reading comprehension and legible writing skills.
• Communication and organization skills in a teamwork environment.
• Experience working as a team member with shared responsibilities is desired.
• Previous work experience in GMP environment is preferred.
• Minimum of general chemistry course and lab
• Self-motivated and hard working

This job requires exposure to the following:

• Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
• Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
• Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 3, including for emergency response.
• Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
• Close quarters, crawl spaces, shafts, man holes, small enclosed rooms, small sewage and line pipes.
• Physical vibration.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
• Narrow aisles or passageways.

This job requires the employee to perform the following type of physical work:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
• Medium work. Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move object

This job requires the following visual acuity requirements:

• preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
• operates machines, such as lathes, drill presses, power saws, and mills where the seeing job is at or within arm's reach; performs mechanical or skilled trades tasks of a non-repetitive nature, such as carpenter, technicians, service people, plumbers, painters, mechanics, etc.
• operates motor vehicles and/or heavy equipment.
• determines the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).

This job requires routine or periodic use of respiratory protection:

• Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR).
• Tight-fitting respirators, such as half-masks or full facepieces which must seal to the face or neck.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $88,000.00 - $111,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Resilience is ushering in an era of “Biomanufacturing-as-a-Service” that we expect will displace in-house manufacturing as well as traditional contract manufacturing and development organizations (CDMOs). We see this as a paradigm shift in biomanufacturing akin to the IT industry’s adoption of Infrastructure-as-a-Service (IaaS) and Platform-as-a-Service (PaaS) that rendered obsolete corporate-owned/operated data centers or corporate servers co-located in hosting facilities.

As a Manufacturing Systems Engineer on the Biomanufacturing Automation team in Digital Operations you will bring to realization the Resilience automation strategy across the manufacturing network.

You’ll work with manufacturing, supply chain, quality and other key stakeholders to define the requirements for the next generation of manufacturing systems implementation. This includes leading the specification, configuration, administration, and maintenance of the manufacturing systems platforms. Be a key collaborator within the Digital team to ensure integrations of all required systems is achieved. You'll need a strong sense of curiosity and growth mindset with a willingness to share and brainstorm new ways to do things.

Responsibilities

• Designs, specifies, and supports the manufacturing systems platforms, including implementing modifications to improve operational performance and product quality
• Analyze, recommend, and implement manufacturing systems projects and enhancements across the Resilience manufacturing network, with focus on manufacturing execution, automation techniques and equipment integration.
• Supports automation activities throughout technology transfer into the manufacturing network and provides continued support throughout manufacturing campaigns.
• Develop, modify, and redline requirements/specifications related to integration of Biomanufacturing Automation platforms (e.g. equipment, software, P&ID, network topology, PFD)
• Provide Subject Matter Expert support to Manufacturing, Technical Operations, and other departments for the design and operation of manufacturing systems platforms.
• Coordinate with Digital Quality and Computer System Validation teams to generate and implement lifecycle documentation and validation protocols.
• Build relationships and collaborate with Manufacturing, Technical Operations/Engineering, Manufacturing Science/Strategy & Technology, and Quality organizations onsite and globally

Qualifications

• Bachelor’s degree in engineering, biotechnology or related field
• 5+ years of experience in life sciences manufacturing operational technology (OT) environments
• Bachelor of Science degree in an Engineering discipline. Preferred area of study: Chemical, Biomedical/Bio, Electrical, or Mechanical Engineering.
• Demonstrated experience with manufacturing systems platforms, including in-depth knowledge of manufacturing technologies and systems at all levels of the ISA95 stack
• Experience with MES (Manufacturing Enterprise System) integration, Batch Control Systems (S88) and automated plant controls systems.
• Tactical knowledge of digital automation systems such as Distributed Control System (DCS) and Programmable Logic Controller (PLC) configuration, field instrumentation installation and troubleshooting, as well as process control experience
• Demonstrated ability to handle multiple competing priorities and projects in a fast-paced environment with a proven track record for delivering results on large, cross functional, global projects
• Hands-on experience with IT change management across domains (security, software, network, hardware, etc.)
• Strong collaboration skills across business, IT, and external vendors/suppliers

Preferred Experience

• Experience with next generation MES platforms (e.g. Apprentice, Tulip) and applications
• Experience with MES integrations to SCADA, ERP, LIMS and other manufacturing critical systems.
• Fluency in supporting the digitization of manufacturing & engineering business process by bringing the IT know-how to business partners in Manufacturing and Technical Operations.
• Builder mentality that seeks to produce innovation, agility, and velocity to support business-as-usual operations and new project implementation.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $85,000.00 - $118,750.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

The Quality Technician II should autonomously perform tasks related to environmental monitoring to support the regulatory requirements of a sterile manufacturing site. This position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting.

Job Responsibilities

• Prepare documentation of activities, actions, and results. Ensure proper documentation practices during job activities. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).
• Complete required training.
• Perform visual inspections.
• Use MODA to collect and analyze samples.
• Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Coordinate activities of support groups.
• Ensure that others carry out laboratory duties in a manner consistent with cGMP.
• Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
• Perform routine sampling activities and associated data entry.
• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
• Read and interpret diagrams, drawings, and other schematics.
• Recommend and initiate activities to ensure area and equipment are maintained in a state of compliance.
• Provide 24/7 "on-call" support to others.
• Provide feedback on service and quality issues on a timely basis.
• This position requires shift work with weekends and occasional extended shifts with possible short-notice schedule shift changes

Minimum Qualifications

• High school graduate, vocational school graduate, or equivalent
• Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language
• Good attention to detail is required.
• Must be capable of keeping accurate records and performing mathematical calculations.

Preferred Qualifications

• Two years of experience in a pharmaceutical production environment
• Working knowledge of MODA, Microsoft applications, SAP, KRONOS, and Trackwise
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $21.50 - $28.50 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Resilience is seeking a talented Senior Scientist to develop next-generation sequencing (NGS) platforms and analytics for a broad portfolio of R&D programs. In this role, you will be responsible for developing and executing cutting-edge genomics assays to expand Resilience R&D’s novel biotherapeutics and biomanufacturing processes. The ideal candidate will have a proven track record of implementing new experimental and analytical approaches with a multidisciplinary team of scientists and engineers. This role requires excellent technical skills, communication, and creativity, backed by a high level of velocity and rigor.

Job Responsibilities

• Drive innovation through technical development of novel sequencing-based platforms and analytics, including whole genome sequencing (WGS), whole exome sequencing (WES), epigenome, transcriptome, single-cell RNA and DNA sequencing (scRNA, scDNA)
• Design, execute, and interpret data from sophisticated experiments and clearly communicate key findings to colleagues within Resilience R&D
• Contribute to experimental plans and technical roadmaps to develop and mature both existing and new assay platforms and techniques
• Identify and advise on novel bioinformatic methods and machine learning approaches to extract meaningful insights from complex data analyses
• Attend and present scientific data to colleagues at internal and external meetings
• Contribute to the delivery of project goals by participating in Agile activities, including scrum team meetings, ideation, and cross-functional interactive sessions

Required Qualifications

• Significant previous experience in life sciences development in an industry context
• Subject matter expertise in NGS and/or single cell sequencing assay design and execution, including sample and library preparation for complex sequencing programs enabling high-throughput, data-driven laboratory operations
• Significant previous experience in genomics, transcriptomics, and/or proteomics, including secondary analysis pipelines
• Significant experience with essential molecular biology concepts and methods such as PCR, purification, gel electrophoresis
• Mastery and consistent practice of good laboratory techniques and scientific experimental design
• Demonstrated track record of independent scientific problem solving using systematic, data-driven experimental design and execution
• Significant experience creating figures, data visualizations, written protocols and/or presentations that clearly distill complex scientific information and roadmaps for a broad audience.
• Demonstrated experience collaborating with colleagues and partners across a range of technical backgrounds and levels of expertise

The required level of technical and professional proficiency is generally gained through 8 or more years of relevant experience in industry and/or academic research and development labs.

Preferred Qualifications

• PhD in molecular biology, cell biology, or a related field
• Experience with current and next-generation genome engineering and sequencing technologies, including high dimensional, multimodal and/or multiomic cell characterization methods
• Experience with current and next-generation automation systems, bioinformatics, and/or machine learning as related to biology
• Direct experience with pre-clinical R&D and IND filing for a cell or gene therapy product or technology
• Familiarity with systems used in biomanufacturing and Good Manufacturing Practice (GMP) methodologies
• Experience designing, performing, and/or analyzing data from cell therapy QC assays (incoming patient QC, inline viability, potency and release assays)
• Experience with novel genome editing nucleases and editing characterization methods (e.g. off-target analyses)
• Experience in interfacing with laboratory automation (e.g., automated liquid handlers) and data analysis software

Other Ideal Personal Characteristics

• Embodies the Resilience phenotypes of grit, rigor, service, EQ+IQ, builder mentality, velocity, and ownership
• Highly organized, self-motivated, and enthusiastic about taking a hands-on approach to collaborative scientific discovery efforts in a fast-paced environment
• Intellectually curious with an open, inquisitive mind regarding the future of medicine and biomanufacturing

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $135,000.00 - $168,750.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

• Fully accountable to manage 4-6 medium or 2-3 large projects with coaching from the Manager of Project Management & Client Support:
• Plan, monitor and ensure completion of all activities outlined in the client Statement of Work (SOW) for each project.
• Prepare change orders for changes of scope in a timely manner.
• Manage the project scope, timeline, resources, deliverables, costs, revenue, margins, risks and issues. Create and maintain project plans within the enterprise project management system. Develop risk mitigation and contingency plans.
• Manage client satisfaction by managing client expectations effectively.
• Predict and resolve project issues and resources constraints within the team with minimal assistance.
• Establish and practice standard project reporting procedures with clients and internal management (i.e. minutes, agendas, etc.). Manage action items and ensure timely close out.
• Work with Production and Development Planning services.
• Identify operational issues to Senior Management and work with them to resolve.
• Facilitate positive team member interactions and manage conflict with minimal assistance.
• Ensure clear, concise and timely communication of project status, tasks and actions.
• Collaborate with Materials Management and Master Scheduler to prioritize projects that will improve the supply chain.
• Ensure involvement and active participation in projects of all necessary departments within Resilience.
• Perform all other related duties as assigned.

• University degree in science related field
• 5 years related experience; preferably in pharmaceutical, biopharmaceutical
• 1-3 years pharmaceutical product development or commercial operations experience
• 5 years project management experience
• Good knowledge of Canadian, US, and European Good Manufacturing Procedures
• Strong leadership and conflict resolution skills
• Well organized and detail oriented
• Ability to prioritize multiple tasks
• Strong interpersonal and communication (written and verbal English) skills, as well as the ability to motivate and influence
• Good knowledge of Continuous Improvement techniques
• Demonstrated, well developed analytical skills

• Direct experience with biological products
• Project Management Professional certification

• Ability to be effective in a highly productive team environment and within high pressure deadline-oriented situations.
• High level of relationship building, judgement, problem solving, influence, persuasion and negotiation for both internal and external clients.
• Ability to adjust quickly to changing priorities and to client and team personalities.
• Ability to work independently in an unstructured environment.

Provide Quality oversight of Digital Systems (Computerized and Software Systems including Laboratory Instrumentation) implementation across all phases of the System Development Lifecycle and associated artifacts at the Resilience’s RTP Facility.

Job Responsibilities

• Oversee the quality of Digital Systems, including Manufacturing & Facilities control systems (such as BMS, MES, PCS/DCS, SCADA) and Laboratory systems (like LIMS, Novatek, CDS), ensuring their implementation across all stages of the System Development Lifecycle and related artifacts complies with quality and regulatory requirements.
• Review and approve life cycle documentation, Change Controls, Validation Plans, URS, FRS, etc.
• Responsible for providing Digital Quality (dQ) support for Deviations and CAPAs associated with Computerized and Software Systems.
• Responsible for presenting and defending dQ and Data Integrity (DI) programs and associated verification artifacts at client audits and regulatory inspections.
• Leads dQ and DI initiatives at the site.
• Leads and works with site cross-functional team to assist in establishing alignment, harmonization, and standardization with corporate-wide Digital Systems Governance Programs (such as SDLC, Data Integrity, Risk Management, Periodic Reviews, and others)
• Ensure site Quality and compliance of GxP activities with respect to internal and/or customer procedures as well as FDA, ICH, EU, and country-specific regulations
• Serves as a liaison between site functions (including Tech Ops, business QC/QA, and Validation) and the central dQ and Data Integrity functions.
• Lead/assist/oversee Digital System / Vendor audits per established risk-based strategy at the site level.
• Lead/conduct/oversee training of Resilience personnel on Electronic Records (21CFR11), CSV, Data Integrity, and relevant Quality SOPs at the site level.
• Represent site Digital Quality at site quality leadership, site Quality Review Board and the central dQ/DI and Governance boards to enable the adoption of corporate dQ and Data Integrity standards.
• Assists in the development systems strategy that pilots and implements efficient, cutting-edge technology on new platforms, including intelligent robotic automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies at the site and central functions.
• Always maintain systems in a state of inspection readiness.
• Assess and advise SMEs on maintaining systems in a state of inspection readiness.
• Establish and report to site leadership and corporate leadership on site-based dQ/DI KPIs.
• Assist in internal audits, customer audits, and regulatory inspections.
• Recruits talent (contract and/or full-time) as appropriate and builds a high-performance team; mentors and coaches' personnel.

Act as a Data Integrity steward with the ability to ensure data accuracy and compliance with ALCOA , responsible to:

• Ensure site adherence to the defined Resilience Data Integrity Program.
• Drive the assessment and risk management and remediation strategy and execution plan for Data Integrity controls (including testing) of digital systems procured by and/or designed/developed in-house at Resilience; collaborate with site stakeholders and central DI program lead to institutionalizing on-site.
• Define appropriate DI controls as part of purchasing and implementing equipment/systems and processes.

Preferred Experience, Education & Qualifications

• Comprehensive knowledge of global GxP regulatory requirements and guidance, including GMP, GLP, GDocP, GDP, and GCP as needed.
• Hands-on experience in developing and managing effective Computerized Software
• Systems Quality Assurance program in support of COTS and customized GxP computerized systems to meet Digital needs.
• Hands-on experience in building and managing teams focused on providing quality oversight of computerized systems validation programs.
• Demonstrated experience in assuring data integrity controls are designed and adhered to in computerized and Software Systems.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
• Demonstrated ability to set goals, perform long-term quality project planning, influence and effectively collaborate with stakeholders to prioritize and align business needs with Resilience strategic goals and budget
• Demonstrated ability to execute responsibilities in a fast-paced environment successfully, collaborating across multiple sites and stakeholders
• Managed a high-performance team.

Minimum Qualifications

• Bachelor’s degree or higher in IT, Computer systems, Life Sciences, Engineering, or a related field
• Minimum of 15 years of pharmaceutical/biotechnology industry experience, with a minimum of 10 years in an IT Compliance/Quality leadership role (with a primary focus on IT/Automation Computerized and Software systems)
• Excellent oral and written communication skills with strong technical writing experience

Physical Requirements:

This job requires the employee to perform the following physical activities:

• Use of fingers
• Stooping
• Kneeling
• Repetitive motion
• Standing
• Grasping
• Walking
• Hearing
• Pulling
• Lifting
• Talking

This job requires the employee to work in the following conditions:

• Activities occur inside and outside

This job requires exposure to the following:

• Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
• Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
• Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
• Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
• Narrow aisles or passageways.

This job requires the employee to perform the following type of physical work:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.

This job requires the following visual acuity requirements:

• Preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $131,000.00 - $166,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

The Supply Chain Analyst will be responsible for maintaining and disseminating an accurate and detailed capacity plan in accordance with our site master production schedule. This role will develop, maintain, and improve planning tools, models, processes, systems, reports, and data outputs to ensure that various functional areas have the information they need to plan their activities. This role will regularly coordinate with commercial leads, project managers, technical transfer personnel, manufacturing leads, and other key personnel in functional areas as assigned to ensure the production plan is feasible and meets the needs of internal and external customers. This role will also identify, analyze, and solve various operational problems.

Essential Position Responsibilities

Tasks include, but are not limited to:

• Build, maintain, and improve reports and dashboards to communicate production schedules, set plant operational targets, monitor execution, and disseminate KPIs (Key Performance Indicators) to site and corporate leadership
• Coordinate with commercial and global supply chain leaders to ensure timely data submissions for our site and corporate S&OP process
• Work with our Production Planner(s) to support, troubleshoot, and maintain our site master production schedule and its system framework for manufacturing and development activities
• Support and drive the establishment, improvement, maintenance, and execution of standardized operations processes which connect demand to supply in a manner that ensures cGMP manufacturing readiness and on-time delivery of project deliverables
• Automate, consolidate, and simplify data processes
• Coordinate with project managers and subject matter experts to resolve scheduling conflicts
• Lead or conduct problem-solving initiatives as needed to eliminate project planning risks, resolve capacity concerns, or otherwise ensure smooth operational execution
• Coordinate/Liaise with functional area leaders to vet schedule feasibility and drive toward timely achievement of production readiness milestones
• Capture and integrate production requirements into our planning process to improve execution reliability
• Support and drive continuous improvement efforts as needed
• Conduct analyses toward advising site leadership of capacity concerns or needed process improvements
• Work with tools such as Power BI, Excel/VBA, ERP systems, SmartSheet, SQL Server, and more to extract, export, clean, organize, analyze, and synthesize data as needed

Requirements

• Bachelor’s degree or equivalent experience in Industrial Engineering, Supply Chain, Biological Sciences, Operations Management, or related field
• Intermediate skill or above in Microsoft Excel (Advanced skill level or strong experience a plus)
• Strong organizational, communication, and problem-solving skills
• Strong attention to detail
• Ability to work in a team environment
• Strong initiative and ability to motivate colleagues diplomatically
• Ability to read, analyze, interpret, and convey technical information
• Strong general computer skills with working knowledge of Microsoft Office products
• Understanding of production and supply chain planning principles
• Continuous Improvement-oriented mindset
• Experience with SQL and/or relational databases a plus
• Experience with SmartSheet, Power BI, or ERP systems a plus
• Supply Chain Analyst I
• Bachelor’s degree or equivalent experience in related field and 0-3 years additional relevant experience
• Supply Chain Analyst II
• Bachelor’s degree or equivalent experience in related field and 4+ years additional relevant experience, master’s degree or relevant professional certification preferred
• Ability to lead medium to large improvement projects and/or conduct S&OP meetings with site leadership
• Sr. Supply Chain Analyst
• Bachelor’s degree or equivalent experience in related field and 4+ years additional relevant experience, master’s degree or relevant professional certification strongly preferred
• Subject matter expertise in data analysis and/or statistical methods including strong experience using data storage systems and data manipulation tools and methods
• Ability to lead large improvement projects and conduct S&OP meetings with site or global leadership

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is occasionally required to:

• Stoop, crouch, reach, walk, pull, push, stand, lift, do repetitive motions, grasp, and talk
• Occasionally be required to exert up to 20 pounds of force, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects
• Frequently be required to perform sedentary and light work
• Occasionally be required to perform medium, and heavy work
• Perform highly detailed work on a computer for eight or more hours per day including preparing and analyzing data and figures

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $57,000.00 - $71,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

In this position, you will play a key role in supporting discovery and understanding of quality attributes for cell-free protein synthesis (CFPS) process development, and analytical development and characterization of biotherapeutics at Resilience. You will work with our scientific and engineering team to analyze critical input materials, cell-free extract and reaction, intermediates, and drug substances using LC-MS (Orbitrap, QTOF, Triple Quad), biophysical assays such as DLS and SEC-MALS methods, endotoxin, and bioburden assays, UPLC, capillary electrophoresis, immunoassays including ELISA and Western blots. The ideal candidate will have deep experience in developing these assays as well as data analysis and interpretation to provide insight into the cell-free process development. This role requires excellent communication and flexibility, backed by a high level of velocity and rigor.

Job Responsibilities

• Develop and utilize LC-MS multiomics platforms to enable discovery of quality attributes for development and quality control of cell-free protein synthesis process.
• Characterize raw materials, cell lysate, cell-free reaction, intermediates using LC-MS systems.
• Develop methods to characterize drug substances using DLS/SEC-MALS methods, endotoxin and bioburden assays, LC-MS intact protein and peptide mapping/PTM analyses, UPLC, capillary electrophoresis, immunoassays including ELISA and Western blots.
• Set analytical strategy, and coordinate/perform in-house and outsourced analytical development and characterization.
• Author analytical method SOPs and qualification protocols/reports.
• Provide technical expertise on analytical methods for biotherapeutic drug substances.

Minimum Experience, Education, Qualifications, And Other Ideal Personal Characteristics

• PhD in Analytical Chemistry, Biochemistry, Biotechnology, or related fields.
• 4+ years’ experience in analytical development for the pharmaceutical/biotech industry.
• Hands-on experience with quantitative and discovery-based LC-MS multiomics workflows.
• Direct experience with a wide variety of analytical methods including DLS/SEC-MALS methods, LC-MS intact protein and peptide mapping, UPLC, immunoassays including ELISA and Western blots, endotoxin, and bioburden assays.
• Excellent command of English (written and oral) and strong communication and interpersonal skills.
• Must be highly disciplined and organized, self-motivated and enthusiastic about taking a hands-on approach to collaborative scientific discovery efforts.
• Availability to work full-time hours at our Oakland, CA location.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $135,000.00 - $168,750.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

RESILIENCE is seeking a talented Scientist I in Analytical Development for the Biologics Franchise who will:

• Function as a key member of the Analytical Development group in Waltham, MA
• Work collaboratively with other leaders throughout the network to advance objectives, priorities, and disruptive technologies
• Operate with the mission to develop and transfer robust therapeutic analytical methods for RESILIENCE Biologics partners and drive development and implementation of innovative internal technology platforms

Job Responsibilities

• Design, develop, optimize, and execute biophysical and analytical chemistry methods to characterize biological materials
• Support upstream and downstream process development
• Support method transfer to GMP lab
• Support scientific research experiments to advance current understanding of bioprocesses
• Author and review SOPs, reports and other technical documents and regulatory submissions.
• Analyze data with available bioinformatic tools, scientifically-sound interpretation and present the data to internal and external stakeholders.
• Serve as analytical project support for internal and external client projects
• Represent Resilience at external events through poster presentations, co-authorship of manuscripts, and other forms of active scientific participation.

Minimum Qualifications

• PhD, Master's or Bachelors Degree in analytical chemistry, biochemistry, molecular/cellular biology or related field.
• PhD - 0-2 years of relevant experience in industry and/or academic research and development labs.
• Masters 2-5 years of relevant experience in industry and/or academic research and development labs.
• Bachelors 5+ years of relevant experience in industry and/or academic research and development labs.
• Demonstrated capabilities in efficient and thorough analytical method development: ability to lead or support the development of an assay from initial concept to a qualified/pre-validated state.
• Extensive experience with experimental design, data analysis, and the organization and presentation of complex scientific data.
• Demonstrated ability to multi-task and be highly productive in a fluid and fast-paced environment.
• A self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
• Ability to communicate and operate effectively within cross-functional teams.
• Excellent data analysis and data management skills

Preferred Experience

• Hands-on experience in LC-MS/MS method development for protein characterization.
• Able to apply scientific principles and concepts to potential innovative platforms and disruptive technologies.
• Strategic and innovative thinker.
• Knowledge of the ICH and USP guidelines for assay qualification and validation.
• Experience in a CMC-development setting.
• Experience with analytical/statistical software (JMP, Softmax Pro, XLfit, Gen5).
• Knowledge of and/or interest in laboratory and equipment automation and maintenance.

Other Ideal Personal Characteristics

• Open mind regarding the future of medicine and biomanufacturing
• Embodies grit, rigor, service, EQ+IQ, builder mentality, velocity, and ownership
• Able to contribute at a very high level, as well as possessing a hands-on manner, when necessary
• Collaborative style, with an ability to build consensus among both internal and external stakeholders

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $90,000.00 - $116,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Provide Quality oversight of Digital Systems (Computerized and Software Systems including Laboratory Instrumentation) implementation across all phases of the System Development Lifecycle and associated artifacts at the Resilience’s West Chester, Ohio Facility.

Job Responsibilities

• Review and approve life cycle documentation, Change Controls, Validation Plans, URS, FRS, etc.
• Responsible for providing Digital Quality (dQ) support for Deviations and CAPAs associated with Computerized and Software Systems.
• Responsible for presenting and defending dQ and Data Integrity (DI) programs and associated verification artifacts at client audits and regulatory inspections.
• Leads dQ and DI initiatives at the site.
• Leads and works with site cross-functional team to assist in establishing alignment, harmonization, and standardization with corporate-wide Digital Systems Governance Programs (such as SDLC, Data Integrity, Risk Management, Periodic Reviews and others).

Act as a Data Integrity steward, responsible to:

• Drive the assessment and risk management and remediation strategy and execution plan for Data Integrity controls (including testing) of digital systems procured by and/or designed/developed in-house at Resilience; collaborate with site stakeholders and central DI program lead to institutionalizing on-site.
• Define appropriate DI controls as part of purchasing and implementing equipment/systems and processes.
• Ensure site Quality and compliance of GxP activities with respect to internal and/or customer procedures as well as FDA, ICH, EU, and country-specific regulations
• Serves as a liaison between site functions (including Tech Ops, business QC/QA, and Validation) and the central dQ and Data Integrity functions.
• Lead/assist/oversee Digital System / Vendor audits per established risk-based strategy at the site level.
• Lead/conduct/oversee training of Resilience personnel on Electronic Records (21CFR11), CSV, Data Integrity, and relevant Quality SOPs at the site level.
• Represent site Digital Quality at site quality leadership, site Quality Review Board and the central dQ/DI and Governance boards to enable the adoption of corporate dQ and Data Integrity standards.
• Assists in the development systems strategy that pilots and implements efficient, cutting-edge technology on new platforms, including intelligent robotic automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies at the site and central functions.
• Always maintain systems in a state of inspection readiness.
• Assess and advise SMEs on maintaining systems in a state of inspection readiness.
• Establish and report to site leadership and corporate leadership on site-based dQ/DI KPIs.
• Assist in internal audits, customer audits, and regulatory inspections.
• Recruits talent (contract and/or full-time) as appropriate and builds a high-performance team; mentors and coaches' personnel.

Preferred Experience & Qualifications

• Comprehensive knowledge of global GxP regulatory requirements and guidance, including GMP, GLP, GDocP, GDP, and GCP as needed.
• Hands-on experience in developing and managing an effective Computerized and Software Systems Quality Assurance program in support of COTS and customized GxP computerized systems to meet Digital needs.
• Hands-on experience in building and managing a team focused on providing quality oversight of computerized systems validation programs.
• Demonstrated experience in assuring data integrity controls are designed and adhered to in Computerized and Software Systems.
• Familiarity with Platform as a Service (PaaS) and Software as a Service (SaaS) models, showcasing an ability to effectively leverage these services for business needs.
• Understanding data lifecycle, including data acquisition, analysis, and reporting, and familiarity with BI tools such as Tableau or similar tools.
• Excellent oral and written communication skills with strong technical writing experience required
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
• Demonstrated ability to set goals, perform long-term quality project planning, influence and effectively collaborate with stakeholders to prioritize and align business needs with Resilience strategic goals and budget
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
• Managed a high-performance team.
• Ability to travel domestically and internationally.

Minimum Qualifications

• Bachelor’s degree or higher in IT, Computer systems, Life Sciences, Engineering, or a related field
• 10 - 15 years of pharmaceutical/biotechnology industry experience
• 7 - 10 years in an IT Compliance/Quality leadership role (with a primary focus on IT/Automation Computerized and Software systems)
• Excellent oral and written communication skills with strong technical writing experience

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $125,000.00 - $158,000.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

This Director of Sales and Business Development role is responsible for growing the Biologics manufacturing business on the Southern CA / South West. This position is accountable for results in a dynamic and fast-paced environment to drive sales volume and profitable revenue for the Biologics & Vaccines Franchise specifically for Drug Substance Manufacturing at the West Coast sites for clinical to late phase and commercial supply. The role is responsible for building an active funnel of new client relationships and open opportunities to facilitate continuous business generation. Ability to generate new clinical and commercial manufacturing prospects, with demonstrated ability to maintain and grow strategic customer relationships within small to mid sized pharma and biotech companies. Position responsibilities include use of business and technical knowledge and experience to drive leads and grow accounts for the Biologics & Vaccines Franchise. This position is field based and requires up to 50 percent travel. The position requires superior leadership behaviors on the Resilience core competencies and non-negotiables, as well as expertise in the functional competencies included in this position profile.

Essential Functions

• Plans and implements sales & business development strategy for the US based Biologics business within the Biologics & Vaccines Franchise, including acquisition and management of business from small-mid-large sized pharma and biotech companies. Cultivation of new and existing relationships, identifying opportunities and new business development skills are critical.
• Works with inside sales and the Strategic team to research, identify and develop new clinical and commercial manufacturing lead prospects from multiple sources including leveraging personal networks, utilization of lead generation platforms, marketing and email campaigns and inbound web leads.
• Represents Resilience by attending trade shows and conferences and maintaining active membership and participation in industry member groups and events. Speaking opportunities are a plus.
• Owns lead generation and conversion for early / late clinical phase and commercial manufacturing programs within the Biologics business through the full sales process from prospect identification to close of business. Includes lead generation, proposal value proposition and pricing creation, follow-up on proposal, terms and conditions/contracting, and negotiations.
• Knowledgeable and collaborates closely with Sales and Business Development within the Biologics Franchise and with other Franchises to generate leads and grow new business.
• Serves as a subject-matter-expert for Biologics manufacturing offerings and coaches and mentors less experienced Sales and Business Development colleagues.
• Owns the customer relationship for Biologics; maintains and drives continuous improvement and communicates customer needs internally. Collaborates internally and externally to facilitate the development of profitable business and sustainable relationships.
• Works closely with Commercial Development to ensure deals are in-line with the needs of the West Coast manufacturing sites.
• Accountable for deal closure and driving account strategy.
• Drives year on year growth of new business from existing and new accounts within their region.
• Maintains accurate customer data and updates to salesforce. Generates call summaries as they occur and monthly reports on activity, metrics, sales targets or forecasts.
• Assists in gathering market intelligence by reporting noteworthy information regarding customers, competitors and the marketplace, internally. Monitors and reports on market and competitor activities and provides relevant reports and information, internally.
• Collaborates with Marketing to request and design specific marketing campaigns to meet the business goals and analyze inbound marketing data/trends to drive new business.

Education And Experience

• Bachelor’s degree in a related life sciences / engineering field (Chemistry, Biology, Chemical Engineering, etc) required. Advanced degree and/or extensive business experience preferred.
• Minimum of 8+ years of experience in sales and business development, project management, contract management, or development and manufacturing experience required.
• Experience in contract negotiations for clinical and/or commercial manufacturing supply agreements
• Experience in Biologics development and manufacturing preferred
• Prior CDMO external sales, account management or business development experience preferred
• This position may be filled at a more senior level depending on experience

Equal Opportunity Statement

At Resilience we believe that the business of business is to improve the state of our world. Each of us has a responsibility to drive Equality in our communities and workplaces. We are committed to creating a workforce that reflects society through inclusive programs and initiatives such as equal pay, inclusive benefits, and more. Resilience is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information or characteristic, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@resilience.com for assistance. Resilience welcomes all. Resilience does not accept unsolicited headhunter and agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $180,000.00 - $232,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Provide Quality oversight of Digital Systems (Computerized and Software Systems including Laboratory Instrumentation) implementation across all phases of the System Development Lifecycle and associated artifacts at the Resilience’s East Norriton, PA Facility.

Job Responsibilities

• Review and approve life cycle documentation, Change Controls, Validation Plans, URS, FRS, etc.
• Responsible for providing Digital Quality (dQ) support for Deviations and CAPAs associated with Computerized and Software Systems.
• Responsible for presenting and defending dQ and Data Integrity (DI) programs and associated verification artifacts at client audits and regulatory inspections.
• Leads dQ and DI initiatives at the site.
• Leads and works with site cross-functional team to assist in establishing alignment, harmonization, and standardization with corporate-wide Digital Systems Governance Programs (such as SDLC, Data Integrity, Risk Management, Periodic Reviews, and others)

Act as a Data Integrity steward, responsible to:

• Ensure site adherence to the defined Resilience Data Integrity Program.
• Drive the assessment and risk management and remediation strategy and execution plan for Data Integrity controls (including testing) of digital systems procured by and/or designed/developed in-house at Resilience; collaborate with site stakeholders and central DI program lead to institutionalizing on-site.
• Define appropriate DI controls as part of purchasing and implementing equipment/systems and processes.
• Ensure site Quality and compliance of GxP activities with respect to internal and/or customer procedures as well as FDA, ICH, EU, and country-specific regulations
• Serves as a liaison between site functions (including Tech Ops, business QC/QA, and Validation) and the central dQ and Data Integrity functions.
• Lead/assist/oversee Digital System / Vendor audits per established risk-based strategy at the site level.
• Lead/conduct/oversee training of Resilience personnel on Electronic Records (21CFR11), CSV, Data Integrity, and relevant Quality SOPs at the site level.
• Represent site Digital Quality at site quality leadership, site Quality Review Board and the central dQ/DI and Governance boards to enable the adoption of corporate dQ and Data Integrity standards.
• Assists in the development systems strategy that pilots and implements efficient, cutting-edge technology on new platforms, including intelligent robotic automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies at the site and central functions.
• Always maintain systems in a state of inspection readiness.
• Assess and advise SMEs on maintaining systems in a state of inspection readiness.
• Establish and report to site leadership and corporate leadership on site-based dQ/DI KPIs.
• Assist in internal audits, customer audits, and regulatory inspections.
• Recruits talent (contract and/or full-time) as appropriate and builds a high-performance team; mentors and coaches' personnel.

Preferred Experience, Education & Qualifications

• Comprehensive knowledge of global GxP regulatory requirements and guidance, including GMP, GLP, GDocP, GDP, and GCP as needed.
• Hands-on experience in developing and managing effective Computerized Software
• Systems Quality Assurance program in support of COTS and customized GxP computerized systems to meet Digital needs.
• Hands-on experience in building and managing teams focused on providing quality oversight of computerized systems validation programs.
• Demonstrated experience in assuring data integrity controls are designed and adhered to in computerized and Software Systems.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
• Demonstrated ability to set goals, perform long-term quality project planning, influence and effectively collaborate with stakeholders to prioritize and align business needs with Resilience strategic goals and budget
• Demonstrated ability to execute responsibilities in a fast-paced environment successfully, collaborating across multiple sites and stakeholders
• Managed a high-performance team.

Minimum Qualifications

• Bachelor’s degree or higher in IT, Computer systems, Life Sciences, Engineering, or a related field
• Minimum of 15 years of pharmaceutical/biotechnology industry experience, with a minimum of 10 years in an IT Compliance/Quality leadership role (with a primary focus on IT/Automation Computerized and Software systems)
• Excellent oral and written communication skills with strong technical writing experience

Physical Requirements:

This job requires the employee to perform the following physical activities:

• Use of fingers
• Stooping
• Kneeling
• Repetitive motion
• Standing
• Grasping
• Walking
• Hearing
• Pulling
• Lifting
• Talking

This job requires the employee to work in the following conditions:

• Activities occur inside and outside

This job requires exposure to the following:

• Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
• Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
• Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
• Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
• Narrow aisles or passageways.

This job requires the employee to perform the following type of physical work:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.

This job requires the following visual acuity requirements:

• Preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $131,000.00 - $166,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

This role is accountable for assisting in the development and oversight of the implementation of the microbial contamination control and viral safety programs at Resilience. This is an exciting opportunity to contribute to the establishment of a robust and comprehensive contamination control program. This role will collaborate with multiple stakeholders to ensure the harmonized execution of contamination control policies across the Resilience network. This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods. The Sterility Assurance Lead is a key support role and reports to the Head of Global Microbial Contamination Control & Viral Safety.

The position will be an onsite position in Durham, NC.

Job Responsibilities:

• Championing sterility assurance principals at the site and serving as the microbial control site technical leader in the areas of aseptic processing, contamination control and viral safety.
• Support the site compliance to the global microbial/viral control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, cleanroom management, microbiological methods and validations including RMM, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments
• Ensure alignment and harmonization regarding global microbiological/aseptic standards and compendial/regulatory requirements
• Responsible for establishing and maintaining the site Contamination Control Strategy (CCS) and management of the gap assessments and risk assessments related to Annex 1 and CCS compliance
• Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial/viral controls
• Lead site microbial and cross contamination LOPA and HACCP risk assessments
• Participate in site Contamination Control Review Committee (CCRC) meetings as the Sterility Assurance SME
• Act as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological and viral safety testing including Rapid Microbial Methods (RMMs), ensuring alignment with the global micro strategy
• Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records
• Support inspection readiness plans and interact with regulatory agencies during inspections on Microbial Contamination Control and Viral Safety program related matters
• Provide microbial SME support for microbial investigations and microbiological/aseptic related challenges to the Resilience network
• Lead efforts, in collaboration with other site and company experts, to ensure compliance and adequate cleanroom design, airflows, traffic flows, cleaning and disinfection, aseptic gowning, aseptic techniques and behaviors.
• Actively participate in industry forums such as PDA, ISPE, BPOG, etc. to lead external engagement and benchmark industry trends and standards

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field
• Minimum of 7+ years of pharmaceutical or biotechnology industry experience, with minimum of 4+ years in a microbial contamination control role.
• Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology
• Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy required
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required
• Experience with microbiological risk assessments
• Comprehensive knowledge of global GMP regulatory requirements for biologics and/or cell & gene therapy products
• Excellent oral and written communication skills with strong technical writing experience required
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
• Knowledge and familiarity with Annex 1

Preferred Experience:

• Background in Microbiology
• Risk Assessment facilitation
• Experience in tech transfer
• Contamination Control strategy experience

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $135,000.00 - $180,000.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

The Site Quality Head is accountable for the quality oversight of the GMP operations at the manufacturing plant located in East Norriton, PA. The Site Quality Head is a key leadership role and reports to the Chief Quality Officer. The position will be onsite in East Norriton, PA.

Job Responsibilities:

• Provides compliance and strategic guidance during the design and qualification of the plant expansions.
• Accountable for recruiting talent and building a high performance Quality team. Mentors and develops personnel and ensures team’s agility, versatility and expertise redundancy.
• Accountable for developing site processes and procedures in order to successfully fulfill the responsibilities for Quality Systems and Compliance, Quality Assurance, Quality Engineering and Quality Control
• Oversees the GMP operations at the East Norriton manufacturing plant and ensures adherence to corporate policies/standards and applicable GMP regulations
• Collaborates with other Quality leaders and stakeholders and assists in the implementation, continuous improvement and lifecycle management of implemented GMP policies and quality management system
• Oversees and/or contributes to the development and execution of Quality Agreements with Clients. Accountable for the timely and compliant delivery of site’s responsibilities in accordance with the Quality Agreement requirements.
• Accountable for product disposition to Clients. Assures timely notification, investigation and mitigation of quality events.
• Accountable for timely notification and effective management of internal and Client-related changes
• Leads site audit and regulatory inspection readiness plan. Leads and hosts Client audits and regulatory inspections. Ensures timely and compliant responses and resolution of identified deficiencies.
• Manages effectively the site’s GMP training program. Champions initiatives for continued learning and development.
• Represents site Quality in corporate planning and joint Client-Resilience forums, as applicable
• Prepares and hosts periodic site Quality Management Reviews to assess the health of the Quality Systems; identifies unfavorable trends and collaborates with stakeholders to ensure their timely mitigation. Contributes to the periodic corporate Quality Management Review and ensures a harmonized implementation of risk mitigation initiatives.
• Develops and manages departmental goals and corresponding budget in alignment with corporate vision and goals

Minimum Qualifications:

• Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, or related field
• Pharmaceutical and/or Biotechnology industry experience, with 5-7 years of experience in a senior quality organizational leadership role
• Comprehensive knowledge of global GMP regulatory requirements for cell & gene therapy products
• Hands-on experience with overseeing GMP operations at a cell or gene therapy manufacturing plant
• Experience with managing regulatory agency inspections
• Proven record with building high performance Quality teams
• Excellent oral and written communication skills
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
• Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence
• Demonstrated ability to successfully execute responsibilities in a fast-pace environment, collaborating across corporate functions and multiple stakeholders

Preferred Qualifications:

• Experience with facility commissioning and qualification

____________________________________________________________________________

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $225,000.00 - $281,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

The Lead Quality Specialist will organize and execute aspects of GMP implementation at the East Norriton manufacturing facility. The successful candidate will possess an understanding of cGMP, specifically building and maintaining quality systems in support of sterile/gene therapy/cell therapy manufacturing. In addition, the ideal candidate must have a proven track record self-situational leadership by way of project leadership or direct supervision of staff.

Job Responsibilities

• Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program.
• Build strong relationships and collaborate closely with CMC/Operations/Development teams and other relevant groups to ensure the manufacturing and testing operations will comply with all US and International regulatory expectations.
• Review documentation for manufacturing activities including but not limited to executed batch records and master batch records.
• Independently performs batch record review.
• Releases batches manufactured at East Norriton.
• Reviews and approves the certificate of analysis.
• Review deviations, OOSs, change controls and/or CAPAs, as needed.
• Author and review technical documents including but not limited to SOPs, risk assessments, various quality reports.
• Compile and report performance metrics for batch review and release.
• Understand risks and delays to batch release and communicate appropriately.
• Mentor, coach, and train Quality Associates in the QA Operations Team.

Preferred Experience, Education & Qualifications

• B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
• Demonstrated quality experience and the ability to collaborate with and effectively influence others.
• Comfortable in a fast-paced, collaborative environment, working with minimal direction and able to adjust workload based upon changing priorities.
• Familiarity with electronic quality systems/software applications.
• Familiarity with electronic laboratory and manufacturing execution systems.
• Working knowledge of GLP/GCP and GxP Regulatory requirements.
• Experience in preparation and participation in regulatory authority plant/site inspections.

Minimum Qualifications

• 7-10 years of relevant life sciences quality experience within quality and/or quality-related functions.
• Demonstrated track record with the successful support of GMP manufacturing and testing environments.
• Experience with a quality batch review and batch release.
• Experience with aseptic, cell therapy and/or viral vector manufacturing is strongly preferred.
• Experience supporting biologics manufacturing.

Other Ideal Personal Characteristics:

• Comfortable in a fast-paced, collaborative company environment, working with minimal direction and able to adjust workload based upon changing priorities.
• Excellent oral and written communication skills.
• Performs with Integrity.
• Ability to collaborate and manage conflict in a fast-paced environment, working across functions.
• Experience in the application of lean methodologies and operational excellence to continuously improve.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $95,000.00 - $132,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Resilience seeks an Analyst II, Quality Control – Product Testing, supporting the Quality Control department. The successful candidate will perform activities for routine testing of manufacturing release and stability samples of gene (viral vector) and cell therapy products.

The QC Analyst II will partner with Manufacturing and QC operations teams to ensure that all required testing is performed, meeting all partner needs in compliance with standard operating procedures and testing methods.

The position will be in our East Norriton, PA facility and will support weekend testing requirements.

Hours:

• 4 x 10 Wednesday to Saturday; 3pm to 1am

Job Responsibilities:

• Perform routine sample analysis in support of manufacturing release and stability activities
• Sample testing of lentiviral vector and CAR-T products using protein-based assays, molecular methods, and cellular assays
• Participate in method qualification/validation activities as necessary
• Analyze, document, and report experimental data in accordance with Resilience requirements
• Maintain, calibrate, and operate analytical equipment
• Qualify equipment related to testing
• Perform method transfer and qualification activities
• Document work in accordance with cGMPs, established business processes and applicable SOPs
• Review data, identify discrepancies, and escalate issues to management
• Author SOPs, methods, protocols, training materials, and reports in alignment with applicable cGMPs, business standards, and intended use
• Investigate OOS or OOT events and develop/implement preventive and corrective actions
• Other activities as assigned

Minimum Qualifications:

• BS in relevant discipline (immunology, cell biology, or related field)
• 2-5 years relevant life science experience
• Experience in mammalian cell culture
• Knowledge of general analytical methods
• GLP or GMP experience required

Preferred Qualifications:

• Background in Cell Therapy/Gene Therapy
• Experience in a laboratory environment
• Ability to thrive in ambiguous or complex situations
• Highly motivated and self-directed
• Thrives in matrix environment
• Excellent interpersonal, verbal and written communication skills

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $72,000.00 - $91,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Resilience seeks an Analyst II, Quality Control – Product Testing, supporting the Quality Control department. The successful candidate will perform activities for routine testing of manufacturing release and stability samples of gene (viral vector) and cell therapy products.

The QC Analyst II will partner with Manufacturing and QC operations teams to ensure that all required testing is performed, meeting all partner needs in compliance with standard operating procedures and testing methods.

The position will be in our East Norriton, PA facility and will support weekend testing requirements.

Hours:

• 4 x 10 Wednesday to Saturday; 3pm to 1am

Job Responsibilities:

• Perform routine sample analysis in support of manufacturing release and stability activities
• Sample testing of lentiviral vector and CAR-T products using protein-based assays, molecular methods, and cellular assays
• Participate in method qualification/validation activities as necessary
• Analyze, document, and report experimental data in accordance with Resilience requirements
• Maintain, calibrate, and operate analytical equipment
• Qualify equipment related to testing
• Perform method transfer and qualification activities
• Document work in accordance with cGMPs, established business processes and applicable SOPs
• Review data, identify discrepancies, and escalate issues to management
• Author SOPs, methods, protocols, training materials, and reports in alignment with applicable cGMPs, business standards, and intended use
• Investigate OOS or OOT events and develop/implement preventive and corrective actions
• Other activities as assigned

Minimum Qualifications:

• BS in relevant discipline (immunology, cell biology, or related field)
• 2-5 years relevant life science experience
• Experience in mammalian cell culture
• Knowledge of general analytical methods
• GLP or GMP experience required

Preferred Qualifications:

• Background in Cell Therapy/Gene Therapy
• Experience in a laboratory environment
• Ability to thrive in ambiguous or complex situations
• Highly motivated and self-directed
• Thrives in matrix environment
• Excellent interpersonal, verbal and written communication skills

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $72,000.00 - $91,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

This role is accountable for assisting in the development and oversight of the implementation of the microbial contamination control and viral safety programs at Resilience. This is an exciting opportunity to contribute to the establishment of a robust and comprehensive contamination control program. This role will collaborate with multiple stakeholders to ensure the harmonized execution of contamination control policies across the Resilience network. This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods. The Sterility Assurance Lead is a key support role and reports to the Head of Global Microbial Contamination Control & Viral Safety.

The position will be an onsite position in West Chester, OH.

Job Responsibilities:

• Championing sterility assurance principals at the site and serving as the microbial control site technical leader in the areas of aseptic processing, contamination control and viral safety.
• Support the site compliance to the global microbial/viral control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, cleanroom management, microbiological methods and validations including RMM, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments
• Ensure alignment and harmonization regarding global microbiological/aseptic standards and compendial/regulatory requirements
• Responsible for establishing and maintaining the site Contamination Control Strategy (CCS) and management of the gap assessments and risk assessments related to Annex 1 and CCS compliance
• Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial/viral controls
• Lead site microbial and cross contamination LOPA and HACCP risk assessments
• Participate in site Contamination Control Review Committee (CCRC) meetings as the Sterility Assurance SME
• Act as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological and viral safety testing including Rapid Microbial Methods (RMMs), ensuring alignment with the global micro strategy
• Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records
• Support inspection readiness plans and interact with regulatory agencies during inspections on Microbial Contamination Control and Viral Safety program related matters
• Provide microbial SME support for microbial investigations and microbiological/aseptic related challenges to the Resilience network
• Lead efforts, in collaboration with other site and company experts, to ensure compliance and adequate cleanroom design, airflows, traffic flows, cleaning and disinfection, aseptic gowning, aseptic techniques and behaviors.
• Actively participate in industry forums such as PDA, ISPE, BPOG, etc. to lead external engagement and benchmark industry trends and standards

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field
• Minimum of 7+ years of pharmaceutical or biotechnology industry experience, with minimum of 4+ years in a microbial contamination control role.
• Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology
• Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy required
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required
• Experience with microbiological risk assessments
• Comprehensive knowledge of global GMP regulatory requirements for biologics and/or cell & gene therapy products
• Excellent oral and written communication skills with strong technical writing experience required
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
• Knowledge and familiarity with Annex 1

Preferred Experience:

• Background in Microbiology
• Risk Assessment facilitation
• Experience in tech transfer
• Contamination Control strategy experience

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $135,000.00 - $180,000.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.