Senior Quality Control Specialist

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on demand, more reliably, and at greater scale to more patients.

About the role:

Allogene is seeking a Senior Quality Control Specialist to provide scientific technical expertise to the Quality Control analytical laboratory. The incumbent will act as Subject matter Expert (SME) for all cell-based methods including but not limited to flow cytometry, potency, cytotoxicity, qPCR and ddPCR, and immunoassays. The candidate will be responsible for the review and approval of test records and documentation generated from the QC laboratory and other contract testing laboratories (CTLs) as needed. The candidate will support daily laboratory operations, including scheduling, training, development/optimization/ troubleshooting of analytical methods. The candidate will perform routine laboratory testing as needed to ensure all operations are completed within agreed upon turn-around time (TAT). The candidate will support deviation investigations, CAPA initiation and completion, and method-related change management as needed. The candidate’s duties are mainly internal within Allogene and some external, providing oversight over contract laboratories. The position will report to the Associate Director, Quality Control and requires onsite presence 5 days per week at our manufacturing facility in Newark, California.

Responsibilities include, but are not limited to:

• Proven flow cytometry expertise with extensive hands-on experience in experimental design, execution, data analysis, and multicolor panel optimization.
• Serve as a Subject Matter Expert (SME) for QC test methods including flow cytometry, cell-based assays, ELISA, qPCR and ddPCR as needed.
• Demonstrate expertise in the operation, maintenance and troubleshooting of instruments; trains and qualifies junior laboratory members on test methods.
• Lead method development activities including design, execution, and analysis of DOE studies.
• Lead method validation and transfer activities, by participating in the design and authoring of validation protocols/reports. Support execution of validation and transfer exercises as needed.
• Define/execute critical reagent qualification programs. Help in establishing and maintaining the critical reagents qualification program for all methods as needed.
• Support the implementation of reference standards and controls programs for analytical methods. Monitor analytical methods performance and escalate any issue.
• Troubleshoot/optimize analytical methods as needed; identify opportunities to improve efficiency.
• Support Associate Director by assisting in laboratory operations, including scheduling, training and troubleshooting to ensure all operations are in full compliance with applicable SOPs and safety guidelines.
• Perform QC analytical testing to support the release and stability of final products as needed.
• Review and approves test records and documentation generated from the QC laboratory and other CTLs, evaluate data, and interpret trends as needed.
• Ensure laboratory maintenance and cleaning activities are performed in a timely manner.
• Perform technical investigations of discrepancies, Out Of Specification (OOS), Unexpected results and support the implementation of corrective and preventative actions.
• Assist with addressing questions during GMP audits and support inspection-related needs as required.
• Support the team’s responsibilities for the performance of all testing and/or for regulatory requirements pertinent to the QC laboratory. May represent QC at operational and cross-functional meetings.

Position Requirements & Experience:

• BS degree in a scientific discipline with minimum 8 years of experience performing relevant activities including working in a GMP environment. Advanced degree preferred (PhD with 2-4 years, MS with 6 years).
• Broad knowledge and strong hands-on experience performing Cell-based assays, Flow cytometry, ELISA, qPCR, and ddPCR.
• Experience in analytical method development/validation/transfer and reagent qualification and maintenance.
• Ability to troubleshoot and optimize methods as needed.
• Experience conducting unexpected/OOS investigations and CAPA initiation
• Thorough understanding of regulatory requirements for drug substance and drug product testing.
• Previous experience in GMP audits and inspection-related supports.
• Ability to solve problems of moderate to complex level.
• Able to be self-motivated and demonstrate good time management skills.
• Ability to multi-task and good adaptability to changing business requirements in a dynamic environment. Able to enjoy to a fast-paced environment. Able to learn new skills rapidly and achieve proficiency.
• Highly detail-oriented team player with a strong interpersonal skill with good verbal and written communication skills. Must have good scientific writing skill. Good organizational and planning skills.
• Proficient in Microsoft Office Suite and Statistical software (JMP).
• Candidates must be authorized to work in the U.S.

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $145,000.00 to $160,000.00 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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