Longevity Industry Jobs

Fate Therapeutics is seeking a highly motivated Senior Director/ Director, Clinical Quality Assurance (CQA). This role is responsible for partnering with Clinical Operations to set the strategy which ingrains Quality and Compliance across all the Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPvP) systems and activities. This role will engage a team of dedicated and cross-functional staff to identify and drive continuous improvement and is an active member of the Quality Team. The Senior Director/ Director, CQA will be instrumental in integrating quality throughout all steps of the GCP and GPvP process, monitoring and auditing using risk assessments and tracking and trending the key metrics to drive improved compliance and quality of the GCP activities. The successful candidate will oversee the execution of compliance programs for Fate clinical studies and is a strong advisor/partner to Fate’s Clinical Organizations to ensure compliance with regulations, guidelines, and best practices. This position will require strong depth of understanding of the FDA and international regulations, and guidance documents, and how they can be applied in a risk-based and phase-appropriate manner. The ideal candidate will foster a quality and continuous improvement culture within Fate to ensure all GCP and GPvP activities and deliverables are compliant and appropriate for the clinical phases and ongoing programs. This is a full-time position reporting to the Executive Director, Quality Assurance, and is located at our corporate headquarters and research facilities in San Diego, California.

Responsibilities

• Refine and maintain clinical quality assurance systems, processes, and procedures in accordance with regulatory requirements and ICH guideline
• Lead and manage Fate’s Clinical Quality Assurance team
• Ensure GCP compliance of ongoing clinical trials
• Closely engages with Clinical Development Operations and Clinical Translational organizations on GCP and GPvP needs, and acts as an advisor to help ensure GCP and GVP compliance
• Support vendor evaluation process and qualification program as it relates to clinical operations for compliance with regulations and company policies
• Provide interpretation and guidance for internal and external customers on GCP related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies
• Identify compliance risks and implement risk mitigation, as applicable
• Monitor, track, and trend GCP non-conformances, deviations, and CAPAs and communicate to management
• Work closely with the clinical operations teams to provide expert clinical compliance information, manage, and identify issues, and support continuous improvement
• Ensure clinical documentation in support of TMF is reviewed and archived appropriately
• Periodically assesses the adequacy of CQA Standard Operating Procedures, with the ability and experience to improve and develop key processes when tasked. Proactively identify gaps or deficiencies in processes and facilitate the remediation.
• Lead or participate in Systems Audits including development of audit plans and tools, managing audit conduct, and reporting the results
• Reviews and provides input to pharmacovigilance documents (Safety Management Plans, Pharmacovigilance System Master File, Aggregate reports, etc.)
• Establish inspection readiness of clinical programs
• Supports any regulatory inspections, should they occur, and assist in audit readiness preparations
• Develop and facilitate GCP/GXP training for functional areas and personal involved in the execution of clinical trials.
• Supports other GxP functions as required

Qualifications

• BSc, MS, or PhD and 10+ years of relevant experience in positions of increasing responsibility in clinical organization and 5+ years in a Quality Assurance role
• Good Pharmacovigilance Practice experience, with the ability to support the growth/development of a pharmacovigilance program
• Significant experience leading external investigator site audits, vendor audits, clinical computerized systems audits, as well as internal process audits
• Strong understanding and knowledge of application regulations and guidance documents associated with GCP and GPvP, as well as the ICH E6 guidelines; significant experience turning these regulations into real-world applications
• Direct experience in the preparation and facilitation of regulatory inspections
• Experience with conducting investigation, root cause analysis, and CAPAs, specifically in the context of GCP regulatory inspection and audit responses is required
• Proven leadership experience and people management skills
• Self-starter and leader who can anticipate issues and bottlenecks and resolve issues effectively with minimal oversight.
• Ability to communicate effectively with people in diverse and different settings
• Strong verbal and written communication skills and ability to work with others and influence in a positive and collaborative manner
• Ability to work in a fast-paced and dynamic environment that will require management of several competing priorities while driving projects forward and meeting program/project deliverables
• Good organizational and project management skills, and ability to perform varied tasks in a functionally independent and consistent manner
• Strong technical writing skills
• Able to independently develop and provide compliance related training programs, as tasked

Working Conditions And Physical Requirements

• Travel may be required (up to 25%)
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. Work is typically performed in an office environment, however there is consideration for a potentially mixed virtual/office situation. Onsite work at corporate headquarters in San Diego, CA

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package
• The anticipated salary range for this role is $200,000 - $250,000

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

Equal Employment Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

Fate Therapeutics, Inc. (FATE) is seeking a Senior Manager or Manager, Regulatory Affairs, who will be responsible for developing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies and submission content plans. The primary responsibility will be to support the CMC regulatory activities related to FATE’s novel cellular therapeutics, for treatment of patients with cancer and immune disorders, in global clinical development. The successful candidate will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to cell and gene therapies, as well as large molecules. This is a full- time position reporting to the Senior Vice President, Regulatory & Quality and is located at our corporate headquarters in San Diego, California.

Responsibilities

• Serve as the Regulatory CMC Lead on FATE cross-functional teams and represent CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally.
• Actively participate on FATE cross-functional teams to develop global submission plans that comply with local regulatory requirements and commitments.
• Support development and execution of global CMC regulatory strategy for multiple cell therapy products, as well as refine such strategies as new data become available.
• Manage the preparation of regulatory dossiers for submission to global Health Authorities; author, review, and/or edit regulatory submission documents and presentations, as necessary.
• Develop and gain agreement with project teams on the regulatory CMC strategy for responses to Health Authority information requests.
• Drive a culture of continuous improvement to ensure compliance with FATE standards, regulatory requirements, and expectations.
• May serve as a single point of contact/subject matter expert on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise.
• Ensure the CMC development regulatory strategy meets global regulatory requirements over the lifecycle of the product and is in alignment with the strategies of FATE, the therapeutic area, commercial, and regional functions.
• Raise issues to FATE Management that affect registration, regulatory compliance, and continued lifecycle management of the product.
• Develop and update contingency plans for issues that may affect registration, regulatory compliance, and the continued lifecycle management of the products in scope.
• Provide accurate regulatory assessments of CMC changes to teams/projects and executes regulatory planning and implementation.
• Set clear outcomes/deliverables for projects and own them with accountability to FATE Regulatory management.
• Manage and provide guidance/training for regulatory staff members, including regular feedback and coaching for professional development.

Qualifications

• A minimum of a Bachelor of Science in biological, pharmaceutical, chemical, or engineering sciences with generally a minimum of 6 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent (required).
• MS, PhD, or PharmD degree preferred.
• Strong knowledge of EU and FDA regulations; an understanding of Health Authority laws, regulations, guidance, and regulation submission routes available for assigned products.
• Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management.
• Experience in biologics required.
• Experience in regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology etc. preferred.
• Experience developing regulatory strategies and an understanding of product development; seen as an expert on product development and how it is applied in global regulatory strategy.
• Experience leading interactions with Health Authorities under supervision of a senior member of the Regulatory staff.
• Demonstrated ability to communicate regulatory requirements.
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.
• Strong attention to detail with high-level verbal and written communication skills.
• Demonstrates model behavior that identifies priorities and encourages others to drive for results.
• Good understanding of competitors in the area and what they are doing in early/late development.

Working Conditions And Physical Requirements

• Up to 20% of travel required
• Onsite work at corporate headquarters in San Diego, CA

$110,000 - $150,000 a year

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

Equal Employment Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

The Director, Clinical Operations is a key member of the clinical operations team, leading the successful execution of clinical trials. The successful candidate will have experience managing complex, early-stage, global and/or pivotal auto-immune trials and oncology trials and a good knowledge of clinical operations, ICH/GCP and regulatory requirements, including those of the FDA. This position contributes to and supports Fate’s research and development efforts to develop next-generation cellular immunotherapies for cancer and auto-immune disorders. This is a full-time exempt position and is located at our corporate headquarters in San Diego, CA. This position reports to the Chief Commercial Officer & Head of Clinical Operations.

Responsibilities

• Operational leadership and management of several clinical studies, including direct management of clinical trial manager, clinical trial associates, and CROs. Oversees operations strategies and tactical planning for the T-cell portfolio of assets in development and/or oncology and auto-immune assets.
• Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Fate SOPs.
• Lead the identification, evaluation, selection, and oversight of clinical trial sites. Partner efficiently, effectively, and professionally with participating study sites to ensure smooth study conduct. Assess expected and reported issues and employ strategic decisions to mitigate risk.
• Support the identification, evaluation, selection, oversight and as applicable, governance of clinical vendors, including Contract Research Organizations and disease specific consortiums/health organizations. As needed, participate in governance meetings/activities to ensure high quality deliverables.
• Implement strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites, as driven by Corporate Objectives.
• Liaise with finance/accounting and clinical outsourcing in communicating forecast/accruals, variances, and changes to study assumptions.
• Responsible for implementation and oversight of Trial Master File for inspection readiness.
• Develop study documents and tools including study protocols, consent forms, project plans, budgets, logs, templates, newsletters, and others, as needed.
• Provide study status by developing and reporting key performance indicators, key risk indicators and quality metrics and periodic reporting to senior management. Escalate study and/or program issues/risks in a timely manner with solid communication skills.
• Oversee study training to investigators, site staff, and internal staff on select study processes.
• Participate in the preparation and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections.
• Participate in RFP and vendor selection process working closely with Clinical Outsourcing.
• Train and mentor new clinical trial staff with appropriate delegation.
• Responsible for the development and direct management of team members.
• Support the strategic identification, assessment, and planning for staff and CRO resourcing.
• May develop SOPs and best practices, participate in, or lead initiatives and facilitate their implementation.

Qualifications

• B.S. or advanced degree with minimum 10 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
• Strong leadership and risk management, effective decision making, and problem-solving skills required.
• Strong knowledge of strategic clinical operations. Extensive experience with clinical study conduct from start-up through close-out, with global trial and CRO management experience highly preferred.
• Extensive Auto-immune trial and Oncology trial experience required.
• Cell therapy experience highly preferred. Working knowledge of relevant GCPs and FDA regulations.
• Experience operating in a matrix organization.
• Experience managing clinical operations staff and CROs.
• Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
• Strong team orientation, with excellent written and oral communication skills.

Working Conditions And Physical Requirements

• Travel may be required (up to 25%)
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. Work is typically performed in an office environment, however there is consideration for a potentially mixed virtual/office situation. Onsite work at corporate headquarters in San Diego, CA.

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package
• The anticipated salary range for this role is $200,000 - $230,000

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

Equal Employment Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

Fate’s Biometrics team is seeking a highly skilled hands-on Clinical Data Management (CDM) leader who will be responsible for leading and overseeing all CDM activities from study start-up through close-out, reporting, and archiving. This position will be responsible for developing CDM processes and standards and providing CDM expertise for cross-functional initiatives. This is a full-time, exempt position reporting to the Senior Vice President, Clinical Translation and is located at our corporate headquarters in San Diego, California. Remote candidates located in the United States may also be considered with travel expectations.

Responsibilities

• Lead and develop a highly functional CDM organization, including formulating CDM strategy, operations, infrastructure, and processes.
• Serve as the in-house CDM expert providing consultation to Clinical Science, Clinical Operations, Biometrics, Patient Safety & Safety Risk Management, and Clinical Translation; lead and/or participate in cross-functional initiatives to maintain operational excellence.
• Select and manage contract research organizations (CROs) and data management vendors; identify potential risks, resolve issues, oversee vendor management plans and review quality metrics; provide guidance, and monitor the progress of DM activities.
• Oversee data query processes by Fate, CROs and data management vendors.
• Provide input and review of clinical research documents (e.g., protocols, case report forms, and clinical monitoring plan).
• Drive the development of clinical database specifications, including eCRF design, user requirements, edit checks, query logic and data validations; oversee the EDC system build, testing, and release.
• Provide oversight for the development and quality control of data management documents including data management plans (DMPs), data validation specifications, and data transfer agreements (DTAs).
• Facilitate the development of key data and metrics reports for data cleaning and review.
• Lead the development and implementation of CDM SOPs, work instructions, standards, and best practices.
• Ensure compliance with SOPs, GCP, ICH guidelines, and other established guidelines of national and international regulatory authorities.
• Maintain/track EDC user management across programs and ensure the integrity, confidentiality, and security of all clinical data.
• Assist data management audit and address audit observations.

Qualifications

• BS/MS/PhD in Life Sciences, Statistics, Informatics, Computer Sciences, or related fields.
• 10+ years of relevant data management experience, including a minimum of 5 years leading the management of external data.
• 5+ years of experience leading CDM teams in the biotech, pharmaceutical, medical device or CRO industry, including experience in multiple therapeutic areas and in various phases of drug development.
• Experience leading CDM infrastructure setup & deployment and CDM process improvements.
• Demonstrated leadership in providing strategic direction to team/project and effectively manage through unexpected events and competing priorities with internal and external partners.
• Extensive experience with effective oversight of external vendors and CROs.
• Experience in leading cross-functional initiatives and change management.
• Deep expertise in CDM and associated technologies, processes and tools, and willingness to learn, develop, and implement innovative data management methodology.
• Experience supporting eCTD submissions through the creation of CDISC/SDTM standard datasets is highly desired.
• Solid knowledge of the current industry best practices, FDA, and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations as related to CDM.
• Experience in clinical trial data collection systems (EDC, eCOA, CTMS, Drug Safety Database Systems, IVRS/IXRS, reporting tools, data visualization, etc.) and practical knowledge of data integration between data collection systems.
• Extensive knowledge of clinical development processes from early to late-stage development.
• Exceptional interpersonal skills and problem-solving capabilities.
• Flexible, team-oriented, and results driven.
• Excellent oral and written communication and presentation skills.
• Oncology clinical trial experience strongly preferred.
• Experience using Metadata Rave strongly preferred.

Working Conditions And Physical Requirements

• Travel may be required (up to 25%)
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. Work is typically performed in an office environment, however there is consideration for a potentially mixed virtual/office situation. Onsite work at corporate headquarters in San Diego, CA

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package
• The anticipated salary range for this role is $200,000 - $250,000

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

Equal Employment Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

Fate Therapeutics is seeking a Scientist to join our Manufacturing Science and Technology (MSAT) team. This position will work alongside a team of scientists and engineers on the late-stage process development, optimization, characterization, validation, and commercialization of Fate’s off-the-shelf, induced pluripotent stem cell (iPSC) product portfolio working closely with Process Development, Analytical Development, Quality Control, Quality Assurance, Manufacturing Operations, Supply Chain, Clinical, and Regulatory functions. This is a full-time, exempt position and is located at our corporate headquarters in San Diego, CA while reporting to the Director, Manufacturing Science and Technology (MSAT).

Responsibilities

• Assess, plan, and execute safety and ergonomic initiatives in support of laboratory and manufacturing operations.
• Completion of quality records such a deviations, CAPAs, change controls, complaints and impact assessments.
• Performing risk management activities including assessment and mitigation planning
• Supporting make-assess-release activities for GMP manufacturing- through technical assessments
• Supporting and executing experiments in a pilot plant
• Representing the system owner for validation and enrollment activities pertaining to process equipment and GMP/pilot plant facilities
• Completion and support of guidance documents for development and GMP purposes
• Proposing data-driven initiatives to optimize and develop iNK/iT processes
• Learn, master, and apply process knowledge in support of experimental design, process implementations (tech transfer, process improvements, decommissioning, etc.) and education/training initiatives
• Collaborating within the MSAT team and broader organization, including but not limited to Process Development, Quality, Product Characterization & Analytical Development, Manufacturing Operations, IT and F&E, to align on business priorities and synergistically complete work

Qualifications

• B.S/ M.S degree in Biochemical/Chemical Engineering, Biotechnology, or Biological Sciences with 6+ years of relevant cGMP experience or PhD degree with 2+ years of relevant experience
• Project management experience preferred
• Cell culture process development experience preferred
• Experience leading and collaborating in cross functional team directives
• Experience implementing phase appropriate technology transfers in clinical and commercial preferred
• Knowledgeable in clinical and commercial scale cell/gene therapy manufacturing
• Experience with process characterization, validation & commercial PPQ deliverables
• Knowledgeable in risk management and techniques such as Gap Assessments, Risk Assessments, cause and effect diagrams, decision trees, interviewing, SWOT analysis, impact matrices, etc.
• Experience with change control management and quality systems to ensure proper planning, execution, communication, and deliverables
• Knowledgeable in QBD methodology and life cycle management such as QTPP, CQA, CPP, CMA, design space, control strategies, validation, monitoring, and continuous improvement
• Experience with cGMP best practices, methodology, regulatory, and compendial guidelines

Working Conditions And Physical Requirements

• Will require working with cells and cell lines of human and/or animal origin
• Will require working with hazardous materials
• On-site work at corporate headquarters in San Diego, CA with occasional travel (<10%)
• Evening and weekend work (Saturday or Sunday with equivalent time off in the week) may be required

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package
• The anticipated salary range for this role is $105,000 - $125,000

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

Equal Employment Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

• Provide clinical data management support to clinical project teams including Clinical Science, Clinical Operations, Patient Safety & Safety Risk Management, and Biostatistics.
• Participate in the review of clinical research documents (e.g., Protocols, Case Report Forms, and Clinical Study Reports).
• Oversee contract research organizations (CRO) and vendors that support our studies.
• Ensures overall quality and timeliness of clinical studies from study implementation to database closure.
• Collaborate with extended team to develop and maintain Data Management Plan (DMP) throughout lifecycle of study project ensuring DMP is followed according to study design and requirements.
• Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to data reconciliation and/or coding.
• With input, develop Case Report Form (CRF), electronic and/or paper.
• Develop clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations that are aligned with Company needs
• Lead EDC database (DB) specification process.
• Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
• Reconcile electronic data transfers from vendor to Sponsor.
• Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
• Ensure the integrity, confidentiality, and security of all clinical data.
• Effectively communicate data management problems and delays to team members.

• Bachelors or Masters in the Life Sciences with 5 or more years Clinical Data Management experience in the pharmaceutical/biotechnology industry. Exposure to Oncology therapeutic area and/or Cell Therapy is preferred but not required.
• Applicable knowledge working with clinical databases such as Oracle, SAS, or other.
• Ability to create and present PowerPoint slides from data for internal and external stakeholders.
• Proficient in MedDRA and WHO Drug coding required.
• Previous experience with EDC required.
• Experience supporting eCTD submissions through the creation of CDISC/SDTM standard datasets is highly desired.
• Detail oriented, proven ability to prioritize activities with efficiency, and multi-task across various projects at different study stages.
• Demonstrate a high level of program leadership, be self-motivated, well-organized, and be able to think strategically.
• Exceptional interpersonal skills and problem-solving capabilities.
• Flexible, team-oriented, and results driven.
• Excellent oral and written communication and presentation skills.

• Occasional evening and weekend work may be necessary
• Travel between office locations as necessary

• Independently execute and analyze in vivo experiments to support product development and test therapeutic hypotheses for cell therapy drug candidates with little or no oversight
• Follow established SOPs and protocols for the culture of tumor and effector cells as required for the execution of planned in vivo studies
• Perform rodent studies including but not limited to parenteral administration of tumor cells, investigational drug products and other agents; precise assessment of clinical phenotype (e.g., tumor size), IV), and the collection of blood, tissues and other biological samples
• Accurately and consistently perform experiments, data collection, analysis, and detailed record keeping in compliance with GLP, GMP and other relevant industry standards
• Collaborate and coordinate with in vivo pharmacology and project team scientists
• Attend departmental and programmatic meetings and present in vivo study-related information (experimental design, recommendations, and resolutions to department leaders and project teams

• B.S. degree in Cell Biology, Immunology, or other related fields with a minimum of 3 years of in vivo laboratory experience in an academic, biotechnology, pharmaceutical setting
• Experience working with preclinical mouse models required
• Experience with mouse tumor models a plus
• Experience with cell/molecular biology a plus
• Strong attention to detail, analytical, time management, organizational and interpersonal skills
• Ability to work independently in a highly-matrixed environment
• Comfortable working in a fast-paced, rapidly changing area of research balancing multiple projects and deadlines
• Excellent time management skills
• Excellent presentation, verbal and written communication skills
• Positive outlook and a team-oriented attitude

• Will require working with cells and cell lines of human and/or animal origin
• Occasional evening and weekend work will be required.
• 100% on-site work at corporate headquarters in San Diego, CA

• Leverage T cell biology, tumor biology, tumor microenvironment expertise in collaborative efforts with other scientists to investigate, develop and implement novel strategies for next-generation CAR-iT cell products.
• Lead, design, coordinate and execute proof-of-concept research with precise data analysis, interpretation, and timely delivery of data packages
• Effectively communicate and present results to multidisciplinary teams.
• Differentiate and evaluate CAR iT cells with in vitro assays (including cytokine release/degranulation and short/long-term killing assay and RNA-seq) and in vivo murine models.
• Perform viral vector-based gene modifications, generate cell lines and primary T cells.

• PhD/MS degree in Immunology or related fields with 3+/7+ years of T cell relevant experience. Previous experience with research in biotechnology or pharmaceutical industry is preferred, but not required.
• Proven track record of leading or contributing to projects in immunology.
• In-depth experience with multi-parameter flow cytometry is a must, preferably 8+ color.
• Extensive aseptic technique and mammalian cell culture experience with a minimum of 3 years of hands-on experience is a must.
• Self-motivated, well-organized, positive outlook, willingness to learn and contribute, and a team-oriented attitude is a must.
• Experience with immune cell functional assays and gene editing of T cells by transfection or transduction is a plus.
• Experience with human CAR-T cells is a plus.
• Knowledge on T cell development, T cell signal transduction, or cellular immunotherapy in oncology is a plus.
• Experience with IncuCyte and/or xCELLigence platforms is a plus.
• Knowledge with single-cell RNA-seq analysis and bulk RNA-seq analysis is a plus.

• Occasional evening and weekend work will be required.
• 100% on-site work at corporate headquarters in San Diego, CA

• Develop, implement, maintain, and continually assess the Company’s QC function for applicable regulated activities to meet internal company standards and external global regulatory requirements.
• Lead and support strategic planning by timely communication of QC deliverables, constraints, risks, and options, and collaborating with key stakeholders.
• Oversee product stability study design, monitoring, reporting, and data trend-analysis, as well as support product release, within a GMP environment.
• Establish robust method qualification and validation strategies to ensure product quality and meet regulatory requirements.
• Own and manage new product introduction for Quality Control.
• Establish and manage a product trending program.
• Own and manage Out of Specification investigations.
• Generate stability specifications for raw materials and products, and support generation of release specifications and Certificates of Analysis.
• Manage method transfer and outsourced testing activities with CMOs.
• Write/review/approve, methods, protocols, and validation reports.
• Write/review/approve deviations, investigations, and CAPAs both within the Company and with CMOs.
• Establish, administer, and maintain policies, standard operating procedures (SOPs), work instructions, and forms relating to the QC function and the QMS.
• Author and review CMC analytical sections for regulatory submissions and annual reports
• Perform periodic internal QC system reviews and audits, as well as participate in preparing for and representing QC in regulatory inspections.
• Implement, perform and oversee internal quality auditing of QC function (including applicable vendors or subcontractors), customer quality audit response, and other QC related quality management system activities.
• Maintain current knowledge of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the QC function remains in compliance with applicable company requirements and global regulations.
• Lead, supervise, and train QC staff.

• Bachelor's Degree in Analytical Chemistry, Life Science, Microbiology, Biochemistry, or related discipline, with a minimum of 10 years in biotechnology, clinical, or pharmaceutical QC laboratory experience is required; advanced degree is preferred.
• Experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is required, with strong knowledge of FDA, ISO, EMA, GMP and ICH requirements applicable to biologics and cell therapies.
• Proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, and excellent interpersonal, organizational, and written and oral communication skills
• Leadership and management skills to grow and manage a high performing Quality organization.
• Experience running ddPCR, ELISA, flow cytometry, and cell-based assays.
• Experience working with cell culture, human blood, and blood products using sterile technique.
• Demonstrated skills in project management and working with vendors and contractors
• Experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
• Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables.
• Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives.

• Will require working with cells and cell lines of human and/or animal origin
• Occasional evening and weekend work will be required
• 100% on-site work at corporate headquarters in San Diego, CA

• Lead the molecular characterization team to develop and execute experimental plans to meet program and corporate research objectives and timelines and to mentor the junior team members.
• Design, optimize, and qualify molecular biology assays, including but not limited to PCR, qPCR, ddPCR, and sequencing for high-throughput, reliable, and in-depth characterization of genetic profiles of cell products following complicated genome editing experiments
• Develop cutting edge molecular assays with the application of NGS technology, identify creative solutions to problems and invent new methodologies and workflows to improve sequencing technologies.
• Develop lab automation (liquid handlers / plate readers, robotics) as needed for improvement of molecular biology assays
• Standardize the methodologies and data analysis to establish statistical criteria
• Use expertise and systematic problem-solving methods to troubleshoot and solve complex assay development issues
• Must be team-oriented and able to communicate research and development findings in cross-disciplinary team meetings as well as with external partners
• Record detailed experimental procedures in laboratory notebooks and controlled documents

• Ph.D. degree in molecular biology or related fields plus 5+ years of analytical development experience. Industrial experience is desirable.
• Expertise in CRISPR-Cas genome editing and molecular and genomic assays for characterization is required.
• Experience in NGS methodologies is preferred; experience in Nanopore platforms a plus.
• Experience in managing the team and projects is preferred.
• Experience in lab automation is preferable.
• Experience in bioinformatics, NGS data analysis, and scientific programming in data analysis tools, e.g. Python, R, ImageJ, JMP, is a plus.
• Desire to understand the fundamental aspect of technologies, and the ability to identify creative solutions to overcome current limitations.
• Ability to design, implement, analyze, and present experiments to demonstrate feasibility of new methods and efficiently move products through pipeline
• Self-motivated, strong problem-solving ability, organizational skills, and attention to details
• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
• Excellent communication and presentation skills.

• Will require working with blood and cell lines of human and animal origin
• Will require working with hazardous materials
• 100% on-site work at corporate headquarters and research facilities in San Diego, CA
• Occasional evening and weekend work will be required

• Independently manage all components of a clinical trial, leading a cross-functional study management team. The assigned clinical trial may be of high complexity or high risk.
• Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Fate SOPs.
• Lead the identification, evaluation, selection, and oversight of clinical trial sites. Partner efficiently, effectively, and professionally with participating study sites to ensure smooth study conduct.
• Implement strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites.
• Review invoices and track study budget according to the forecast working closely with finance and clinical business operations.
• Manage multiple clinical study vendors with oversight of activities.
• Responsible for implementation and oversight of Trial Master File for inspection readiness.
• Develop study documents and tools including study protocols, consent forms, project plans, budgets, logs, templates, newsletters, and other, as needed.
• Provide study status updates and reports to senior management.
• Lead ongoing study data reviews and data cleaning activities.
• Provide oversight of CRAs assigned to clinical trials and provide oversight of activities related to site qualification, initiation, interim monitoring, and close-out visits, as needed.
• Develop and deliver study training to investigators, site staff, and internal staff on select study processes.
• Develop processes and provide oversight of study supplies management.
• Participate in the preparation and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections.
• Conduct internal meetings for assigned clinical trial(s)
• Conduct external meetings (e.g., Investigator Meetings), conferences and events.
• Participate in RFP and vendor selection process working closely with Clinical Business Operations.
• Train and mentor new clinical trial staff with appropriate delegation and may be responsible for dotted-line management of team members.
• Escalate study issues/risks in a timely manner with solid communication skills.
• May develop SOPs and best practices and facilitate their implementation.

• B.S. degree with minimum 8 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
• Strong leadership, effective decision making, and problem-solving skills required.
• Strong knowledge of and strategic clinical operations. Strong experience with clinical study conduct from start-up through close-out, with global trial and CRO management experience highly preferred.
• Solid tumor, lymphoma or multiple myeloma experience required.
• Immunotherapy or cellular therapy experience highly preferred.
• Working knowledge of relevant GCPs and FDA regulations.
• Experience operating in a matrix organization.
• Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
• Strong team orientation, with excellent written and oral communication skills.

• May require occasional evening and weekend work.
• Full-time onsite work at Company’s headquarters in San Diego or in South San Francisco, California.
• Minimum 10% time traveling to clinical sites and clinical/professional meetings. May include international travel.

• Cell culture of iPSCs for genome editing assay development.
• Perform and optimize cell-based and biochemical assays, e.g. cell transfection, PCR, qPCR, ddPCR, NGS DNA library preparation, sample quantification, sequencer operation, and generate reports on assays performed in timelines to meet program and corporate objectives.
• Participate in process and assay development activities for genome editing pipeline
• Communicate research and development findings in cross-disciplinary team meetings as well as with external partners
• Record detailed experimental procedures in laboratory notebooks and controlled documents

• BS in cell biology, molecular biology or similar. MS degree preferred.
• Relevant experience is required: 3+ years of hands-on cell culture and molecular biology experience (industry experience highly preferred).
• Experience in NGS library prep methodologies is preferred.
• Prior experience in CRISPR-Cas genome editing is plus.
• Experience in managing high throughput samples is a plus.
• Understanding in cell and molecular biology and technology, critical thinking, analytical skills, trouble-shooting ability, and attention to detail.
• Collect, maintain, and organize primary data and analyses accurately and timely in accordance with company policy
• Capability to multi-task, be independent, self-motivated, as well as work in a highly collaborative setting.
• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
• Excellent communication and presentation skills.

• Will require working with blood and cell lines of human and animal origin
• Will require working with hazardous materials
• 100% on-site work at corporate headquarters in San Diego, CA
• Occasional evening and weekend work will be required

• Leverage T cell biology, tumor biology expertise in collaborative efforts with Scientists, Associate Scientists and Research Associates to develop, influence and enhance our understanding of iPSC derived T cell products.
• Design, plan, execute, and manage proof of concept studies spanning multiple programs to assess cell therapy products’ function and potential efficacy.
• Execute viral vector-based modification of cell lines and primary cells.
• Generate primary human cell material, iPSC derived cells, and tumor cell lines using meticulous aseptic cell culture technique.
• Perform in vitro functional assays and in vivo xenograft/PDX tumor models to evaluate T cell product candidates in combination with existing immunotherapy/chemo/radiotherapeutic modalities.
• Collect, maintain, and organize primary data for timely analysis in accordance with company policy.
• Prepare and present data to team members and larger multidisciplinary teams.
• Take initiative to perform routine laboratory tasks and upkeep of the lab space in order to maintain conditions that are conducive to excellent scientific work.

• Ph.D. in Immunology, preferably with focus on T cell biology, with 0-4 years relevant experience in an academic, biotechnology, or pharmaceutical setting.
• Experience with high dimensional flow cytometry, panel design and downstream analysis, with an emphasis on developing throughput assays using primary cells and ex vivo (tissue isolated) immune and tumor cells. Industry method and assay development activities a plus.
• Experience with mammalian cell culture, preferably with in vitro assessment of lymphocyte effector functions, including, but not limited to, tumor cell cytotoxicity killing and cytokine release/profiling assays.
• Strong background in tumor-immune cell interactions, with a central focus on T cell biology, solid tumor microenvironment (TME) knowledge and in vivo CDX tumor modeling.
• Experience with multi-parameter phenotypic and functional analysis of T cells using flow cytometry, gene expression, cytokine/immune profiling, and cytotoxicity assays.
• Outstanding data management and interpretation using statistical and/or data management programs e.g., Prism or equivalent.
• Excellent coordination and communication with multiple groups for scheduling and execution of experiments.
• Experience leading, mentoring, and supervising team members preferred.
• Experience working in a fast-paced environment with proven experience thriving in a cross-functional team setting.
• Excellent written and oral communication skills. Experience writing and reviewing industry research and QC controlled reports desirable.

• Will require working with cells and cell lines of human and/or animal origin.
• Occasional evening and weekend work will be required.
• 100% on-site work at corporate headquarters in San Diego, CA

• Develop global medical affairs strategy with planning and activities of cross-functional teams working closely with Clinical Development, Commercial, and other stakeholders.
• Interact with experts in the field to obtain feedback on pipeline to generate medical insights that inform global product and medical strategies, and drive initiatives for new data generation, interpretation, and dissemination.
• Provide cross-product Global Medical Affairs strategic perspective to key development and commercialization forums.
• Contribute medical affairs strategy and deliverables to the global development plan for each molecule in development as applicable.
• Manage opinion leader relationships and process to evaluate and support investigator-initiated studies of pipeline products as appropriate.
• Define resource needs, and manage budget planning and resource allocation across hematology and solid tumors.
• Build and maintain high level and detailed timelines for medical affairs deliverables.
• Drive major international Congress Planning, strategically targeting relevant meetings and assuring data for development programs meets strategic objectives. Attend medical scientific meetings and congresses to represent the company.
• Identify training needs, build, develop and oversee training activities in collaboration with key stakeholders and ensure implementation of medical training programs for medical team and other cross-functional members as appropriate.
• At appropriate time in product life cycle, conduct annual data gap analysis to develop and evolve the product data generation plan for each global asset through its lifecycle.
• Oversee development of clinical manuscripts, presentations, international symposia, and posters.
• Provides input into regulatory documents, including product labeling.
• Where applicable, manage junior-level staff as direct reports.

• MD is strongly preferred, PhD, PharmD, or relevant advanced degree is required
• Minimum 10 years of experience in pharma, biotech drug development, or academia
• Excellent analytical skills as applied to medical, scientific and technical information \
• Demonstrated ability to accurately and effectively evaluate medical/scientific literature and develop effective medical strategies and communication strategies
• Prior oncology or hematology-oncology experience
• Prior experience with gene and/or cell therapy a plus
• Extensive knowledge of drug development and/or experience in more than one functional area such as clinical development, med affairs, translational development, regulatory, commercial, safety, etc., to assure broad understanding of the pharmaceutical development
• Prior NDA, or BLA filing/submission & launch experience
• Comfortable with ambiguity and developing innovative pathways within a high-paced environment and with high expectations for work product
• Ability to exercise sound judgement and work independently
• Strong strategic thinking and the ability to influence key internal and external stakeholders
• Excellent written, verbal and interpersonal communication skills
• Proven ability to work with and influence diverse, cross-functional teams including the ability to synthesize diverse perspectives, identify unique opportunities and help decision making at the program and portfolio levels
• Strong ability to interpret complex scientific data and concepts, and applies appropriate insights into the commercial model and planning
• In-depth understanding of business objectives and how these translate into marketing priorities
• Adept at managing effectively across all levels within an organization and documented success in working with senior executives
• Independent thinker, hands-on mindset, and a detail-oriented approach to getting the work done

• Preferred candidate will be local to the corporate headquarters in San Diego, CA or to our San Francisco Bay location. Remote candidates may also be considered.
• Occasional evening and weekend work as needed
• Travel anticipated up to 30% of time

• Participate in iPSC line and feeder cell line development by adhering to established cGMP SOPs and Batch Records covering, but not limited to: media preparation, cell culture and scale up, cellular reprogramming, genetic engineering and single cell sorting.
• Execute and document batch records and SOPs in compliance with safety policies, quality system and cGMP.
• Support and validate pilot studies prior to iPSC master cell bank generation.
• Edit and review controlled documents as needed to ensure defined quality objectives are met.

• BS or MS in cell biology or similar discipline with a minimum of 4 years of experience in cell culture and aseptic techniques.
• Preferred experience in one or more of the following: experience in cGMP manufacturing, cellular reprogramming and/or iPSC culture, flow cytometry, or CRISPR engineering.
• Self-motivation with demonstrated ability to work both independently and in a team-oriented cross functional environment.
• Excellent communication, strong attention to detail with the ability to multi-task and prioritize multiple responsibilities simultaneously, time management/organizational skills.
• Positive outlook and a team-oriented attitude.

• Design, execute, and analyze experiments to develop and refine the parameters for iPSC expansion and iCD34 differentiation for iPSC-derived NK and T cell product manufacturing.
• Identify critical process parameters and develop strategies aimed at improving robustness of Fate’s manufacturing platforms.
• Evaluate and implement new technologies for specific manufacturing processes, as appropriate.
• Collaborate with the Manufacturing team to identify potential process improvements and design appropriate experiments to evaluate and implement those changes.
• Perform characterization of stage-specific processes utilizing flow cytometry, FACS sorting, gene expression profiling, and media analysis.
• Collect, organize, and analyze data in a timely manner and in accordance with company policy.
• Collaborate with cross-functional teams to drive programs forward to meeting program goals including IND submission, CMC amendments, initiation of manufacturing, etc.
• Present data to Process Development team, program-specific teams, and the bigger R&D group.

• MS degree with a minimum of 5 years of experience in a relevant biological or technical field
• In-depth experience with adherent mammalian cell culture
• Hands-on experience with human ES/iPSC culture is preferred
• Prior experience with gene expression data analysis would be an advantage
• In-depth experience with multi-color flow cytometry data acquisition and manual analysis using FlowJo
• Excellent data organization and analysis using Excel, Prism or Spotfire
• Working knowledge of statistical and analytical tools, such as JMP, is preferred
• Prior experience in Process Development or Manufacturing setting is a plus
• Strong attention-to-detail, verbal, and written communication skills
• Comfortable in adjusting workload based upon adjustment of priorities
• Ability to work independently, multi-task, and work effectively in a dynamic and fast-paced setting
• Positive outlook, willingness to learn and test new ideas, and a desire to work collaboratively in a team environment

• Will require working with cell lines of human origin and/or animal origin
• Will require working with hazardous materials
• 100% on-site work at corporate headquarters in San Diego, CA
• Evening and weekend work as necessary

• Both in collaboration with user groups and independently, participate in the design, optimization, and execution of innovative flow cytometry methods and technical protocols
• Engage scientific community through technical consultations relating to experimental setup and instrument operation
• Daily operational support of scientific staff and instrument up-keep in a fast-paced flow cytometry core environment
• Provide operator-assisted cell sorting for Fate Research and Development teams
• Carry out routine periodic instrument maintenance
• Develop and maintain SOPs for instrument operation, quality control, and maintenance
• Daily startup and QC of analytical flow cytometers and high-speed sorters
• Provide operator-assisted cGMP-regulated cell sorting for Fate iPSC master cell bank generation and related sorting processes
• Execute and document SOPs and batch records with a high level of compliance to safety policies, quality systems, and cGMP guidance
• Instill and propagate fundamentally sound flow cytometry principles and practices while instructing new and/or novice Fate employees on basic to intermediate analytical cytometer use

• B.S. or M.Sc . degree in a biological sciences discipline, engineering, chemistry, physics, or related field
• 2+ years of experience working in a flow cytometry core or 4+ years of experience utilizing flow cytometry as a laboratory application
• Experience in setup and operation of analytical and sorting flow cytometers
• Ability to successfully perform single cell sorting
• Experience operating high throughput samplers for analytical flow cytometers
• Ability to design multi-color immunophenotyping antibody panels consisting of 6 or more markers
• Familiarity with high dimensional flow cytometry (e.g., spectral cytometry, CyTOF) is a plus
• Able to perform general lab techniques, including cell line culturing and antibody panel staining. Primary cell culture experience highly desirable
• Excellent aseptic technique and attention to detail
• Experience working in a regulated environment (e.g., GxP, CLIA) applicable to cell sorting is highly desirable
• Strong familiarity with post-acquisition analysis software for flow cytometry data (e.g., FlowJo, OMIQ, FCS Express, or Cytobank)
• Strong computer skills
• Ability to troubleshoot technical and experimental challenges
• Excellent communication and organizational skills
• Proactive team-oriented attitude

• 100% on-site work at corporate headquarters in San Diego, CA
• Must be willing to work in a biosafety level 2 (BSL-2) environment
• Must be able to lift a maximum of 50 lbs.
• Must be able to work with high voltage equipment
• Must have reliable transportation
• Evening and weekend work as needed

• Provide scientific and technical support to identify, evaluate, and advance novel binders for development of targeted therapies including CARs.
• Manage and provide oversight for Fate’s binder discovery initiatives (CRO management, antibody characterization, etc.)
• Develop and execute screening methodologies and assays for evaluating the biophysical properties of candidate binders (i.e., affinity, specificity/cross-reactivity, aggregation, stability, etc.).
• Design and generate plasmid constructs, lentivirus, and cell line tools as needed.
• Develop and execute experimental plans to collaborate with other teams and to meet program objectives and timelines.
• Provide strategic direction and oversee implementation of binder identification and screening pipelines
• Communicate research and development findings in cross-disciplinary team meetings as well as with external partners.

• PhD in Molecular Biology, Biochemistry, or related fields with 7+ years postdoctoral and industry experience is highly preferred.
• In-depth experience with antibody/binder generation, screening, and characterization (specificity, affinity, epitope binning, aggregation, stability, etc.)
• Extensive experience in molecular cloning, vector construction, lentivirus production/transduction, and transgene expression.
• Antibody and protein characterization and assay development (ELISA, cell binding, Biacore/Octet, HPLC, SDS-PAGE) is preferred.
• Protein expression in mammalian systems (CHO or 293) and protein purification (FPLC, protein A, affinity column) experience is a plus.
• Extensive experience in cell culture and assay development (primary and tumor cell culture, transfection, viral transduction, multi-color flow cytometry, FACS, reporter assay).
• Experience with gene editing technologies including gRNA design, donor template building, and knock-in analysis is a plus.
• Experience with CAR design, iPSCs, T and NK cells is plus.
• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
• Ability to design, optimize, and perform experiments in a high-throughput manner is a plus.
• Demonstrated success in working in a cross-functional team environment.
• Excellent organizational skills with record keeping abilities.

• Will require working with blood and cell lines of human and animal origin
• Will require working with hazardous materials
• 100% on-site work at corporate headquarters and research facilities in San Diego, CA
• Occasional evening and weekend work will be required

• Administrate and direct a laboratory testing schedule across the QC function, incorporating lot release, stability, raw material, qualification, and all other required testing.
• Oversee Fate Therapeutic Inc.’s QC Sample Management Program, ensure timely submission of samples for testing to contract organizations, proper chain of custody, and test needs.
• Maintain, and continually assess the internal CTO sample submission on-line process to ensure smoothly sample handling and shipment from each department to CTO vendors
• Design and implement process maps to support streamlined laboratory operations such as specialized inventory programs and laboratory supplies
• Contribute to the development and continuous improvement of the sample management and raw material handling
• Write/review/approve deviations, CAPAs, and change control records for QC activities
• Write/review/approve QC procedures, protocols, and reports
• Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the function remains in compliance with applicable company requirements and global regulations
• Onboard new materials and reagents and participate in materials risk assessment

• B.S in Analytical Chemistry, Life Science, Microbiology, Biochemistry, or related discipline with a minimum of 6 years of experience in biotechnology, clinical, or pharmaceutical QC laboratory experience is required. Advanced degree is preferred.
• 1+ years of experience at managing a group with 2-3 people required
• Good organization skill and interpersonal communication skills
• Experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is highly preferred.
• Experience working on 5S, Lean, Six Sigma project is a plus
• Demonstrated success working with multiple contracts testing labs
• Cell therapy Experience is preferred
• Strong scientific, analytical, problem solving, and communication skills as well as sound judgment, with the ability to work both independently and effectively with others

• Will require working with cells and cell lines of human and/or animal origin
• Occasional evening and weekend work will be required
• 100% on-site work at corporate headquarters in San Diego, CA

• Perform all functions to support phase-appropriate development and optimization of assays used for in-process and final product lot testing
• Perform method performance studies to evaluate suitability of the developed methods
• Perform assay transfer and training of QC team and provide ongoing technical support including document review
• Perform previously established methods in support of process development, product release and stability, and product characterization in accordance with good documentation practices
• Perform data analysis and data trending to track assay performance
• Work closely with other teams, including PD, QC, and QA, to author and revise QA-controlled documents as required
• Culture, maintain, and generate well-documented banks of cell lines and primary cells required for assay development
• Maintain detailed experimental records, interpret data, and present data to functional and project teams
• Order and maintain stocks of lab reagents and samples

• B.S. or M.S. degree in a biological field with 3-5 years of relevant lab experience in flow cytometry, plate-based, and/or cell-based assay development (preferably in biopharmaceutical organization)
• Hands-on experience (equipment and software) with flow cytometry (CytoFlex preferred), plate readers, and automated cell counters is required
• Working knowledge of statistical and analytical tools is required
• Experience with cell culture and aseptic technique is required
• Experience in analyzing assay results/data using software, such as FlowJo, FCS Express, CytExpert, Softmax Pro, etc., is strongly preferred
• Experience with bioassay/bioanalytical development in cell therapy field is strongly preferred
• Experience identifying areas of improvement and troubleshooting assays is strongly preferred
• Excellent communication, time management, record keeping, presentation, and data analysis skills are required
• Familiarity with FDA, ICH, and USP guidelines for analytical method development is a plus
• Ability to work efficiently in a dynamic environment is required

• Will require working with cell lines of human origin
• Occasional evening and weekend work will be required.
• 100% on-site work at corporate headquarters in San Diego, CA

• Handles processing of samples for shipment to vendor labs.
• Supports the Lab Operations team with clinical samples’ receipt and accessioning (data entry of patient information) into a laboratory system.
• Handles sample storage inventory and assists with filing laboratory records.
• Assists in managing reagent inventory for the Translational Science lab.
• Performs other routine laboratory support production activities.
• Follows laboratory’s procedures and safety guidelines for all of the above processes.
• Performs other clerical and administrative functions within the laboratory operations, and as directed by laboratory management.

• Minimum high school diploma or general education degree (GED).
• Experience in a laboratory setting.
• Experience in data entry.
• Highly organized, attention to detail, excellent record keeping abilities, and strong problem-solving skills.
• Able to work productively, effectively and independently in a fast-paced environment.
• Familiar with MS Office a plus.

• 100% on-site work in our laboratories at corporate headquarters in San Diego, CA.
• Comfortable working in a lab setting.

• Create a strong team environment that demonstrates timely and effective communication, a sense of urgency, flexible and adaptable to support the company’s growth plans and New Product Introduction (NPIs)
• Manages IP supply planning and timelines to ensure alignment with overall clinical development plan. Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals as needed
• Coordinates courier shipments and deliveries and manages the courier relationship. Oversees international shipments requiring customs paperwork for worldwide shipment of IP and clinical trial materials. Coordinates with international Qualified Person for release of IP for use
• Responsible for working within established timelines of IP manufacturing, labeling, release, distribution, and return/destruction, and/or helping to establish these timelines.
• Manages and tracks IP inventory; advises management team of potential shortages and makes recommendations for resupply activities based on usage trends and forecasting
• Oversees IP shipment orders according to supply plans, or as requested by Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites. Works with manufacturing to complete this activity and manages all aspects of the process
• Work with cross-functional teams to develop specifications and user testing of Interactive Response Technologies (IRT) systems provided by 3rd party vendors while leading the efforts for clinical supply management functionality
• Monitor and manage clinical supply activities through IRT from study start-up through study closure
• Ensure appropriate system documentation is transferred to TMF and inspection readiness as needed
• Participate in domestic and international shipping qualification and validation studies
• Reviews drug return and destruction and administration records
• Lead trouble shooting effort for investigational product shipment issues
• Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors as needed

• B.S. / B.A. degree
• Minimum 5 years related experience in Pharma/Biotech industries or regulated industry with 3 years of people management experience, Cell & Gene Therapy experience preferred
• Extensive knowledge and experience with Interactive Response Technologies (IRT) such as IXRS
• Knowledge of ICH/GCP and regulatory guidelines/directives. Disease/therapeutic area knowledge a plus.
• Strong problem solving, decision making, planning and analytical skills to drive performance in a fast-paced but high growth small company environment.
• Able to adjust workload based upon changing priorities
• Must work well in a team environment with admirable interpersonal and communication skills (written and verbal).
• Strong leadership and cross-functional collaboration to drive change.
• Intermediate to Advanced skills with MS Word and Excel.
• Study Tools including electronic system skills IVRS/IWRS, CTMS, EDC

• Occasional evening and weekend work will be required.
• 100% on-site work at corporate headquarters in San Diego, CA

• Scan, log, and file documents
• Scan, log, and stage documents for offsite storage
• Enter data in Quality’s internal system(s) when processing documents
• Perform other Document Control related duties as assigned

• High School Diploma or equivalent
• Excellent organizational skills with a professional demeanor and the ability to work well in a team environment with cross-functional team members
• Excellent writing skills and proficiency with MS Office applications, particularly Word and Excel
• Strong attention to detail and communication skills
• Able to work independently and prioritize tasks in a fast paced and dynamic environment

• Full-time onsite work at company’s headquarters in San Diego, CA
• Frequently required to work on a computer up to 8 hours a day
• Occasionally required to stoop, kneel, and lift up to 50 pounds

• Lead a team to provide core molecular biology support to iPSC MCB generation
• Support process development and manufacturing runs of MCB generation by screening, characterization, and release testing using molecular biology assays including conventional PCR, qPCR, ddPCR and sequencing
• Design, optimize, and validate assays and establish quality-controlled SOPs
• Coordinate with QA/Facilities/Manufacturing to establish controlled lab and protocols for GMP production of plasmids
• Manage multiple projects by communicating with cross-functional teams, setting priorities and timelines, and ensuring timely delivery of high-quality results
• Author research reports and contribute to IND filing
• Communicate research and development findings in cross-disciplinary team meetings as well as with external partners

• Ph.D. in molecular biology or related discipline with 7+ years of relevant experience in industry.
• Expertise in design, optimization, qualification, and troubleshooting of conventional PCR, qPCR, ddPCR assays.
• Clear understanding of standard methodology in analysis of outcome of genetic engineering.
• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
• Experience working with cGMP compliant/quality-controlled procedures.
• Proven track record of managing multiple projects and managing and developing personnel.
• Excellent communication and presentation skills.
• Demonstrated success working in a cross-functional team environment.

• Will require working with blood and cell lines of human and animal origin
• Will require working with hazardous materials
• 100% on-site work at corporate headquarters in San Diego, CA
• Occasional evening and weekend work will be required