Senior Quality Control Specialist

Allogene Therapeutics•Newark, NJ

3d•Onsite

About The Position

Allogene Therapeutics is seeking a Senior Quality Control Specialist to provide scientific and technical expertise to its Quality Control analytical laboratory. The role serves as a subject matter expert for cell-based methods, including flow cytometry, potency and cytotoxicity assays, qPCR, ddPCR, and immunoassays. The specialist reviews and approves test records and documentation from the QC laboratory and, as needed, contract testing laboratories, evaluates data, and interprets trends. The position supports daily laboratory operations, including scheduling, training, method development and optimization, and troubleshooting. It performs routine laboratory testing as needed to meet agreed turn-around times and supports deviation investigations, CAPA, and method-related change management. The role is primarily internal, with some external oversight of contract laboratories, and reports to the Associate Director, Quality Control. Onsite presence is required five days per week at Allogene’s manufacturing facility in Newark, California.

Requirements

Bachelor’s degree in a scientific discipline and at least 8 years of experience performing relevant activities, including work in a GMP environment.
Broad knowledge and strong hands-on experience with cell-based assays, flow cytometry, ELISA, qPCR, and ddPCR.
Experience in analytical method development, validation, and transfer, and in reagent qualification and maintenance.
Ability to troubleshoot and optimize methods.
Experience conducting unexpected-result and OOS investigations and initiating CAPAs.
Thorough understanding of regulatory requirements for drug substance and drug product testing.
Previous experience supporting GMP audits and inspections.
Ability to solve moderately to highly complex problems.
Self-motivation and good time-management skills.
Ability to multitask and adapt to changing business requirements in a dynamic environment.
Ability to work in a fast-paced environment and learn new skills rapidly.
Strong attention to detail, teamwork, interpersonal skills, and verbal and written communication skills.
Good scientific writing, organizational, and planning skills.
Proficiency in Microsoft Office Suite and statistical software such as JMP.
Must be authorized to work in the United States.

Nice To Haves

Advanced degree preferred: PhD with 2–4 years of experience, or MS with 6 years of experience.

Responsibilities

Serve as a subject matter expert for QC test methods, including flow cytometry, cell-based assays, ELISA, qPCR, and ddPCR.
Design, execute, analyze, and optimize flow cytometry experiments and multicolor panels.
Operate, maintain, and troubleshoot laboratory instruments, and train and qualify junior laboratory members on test methods.
Lead method development activities, including the design, execution, and analysis of design-of-experiments (DOE) studies.
Lead method validation and transfer activities by participating in the design and authoring of protocols and reports; support execution of validation and transfer exercises.
Define and execute critical reagent qualification programs and help establish and maintain qualification programs for methods.
Support implementation of reference standards and controls programs for analytical methods.
Monitor analytical method performance, escalate issues, troubleshoot and optimize methods, and identify opportunities to improve efficiency.
Assist the Associate Director with laboratory operations, scheduling, training, and troubleshooting to ensure compliance with applicable SOPs and safety guidelines.
Perform QC analytical testing to support final product release and stability as needed.
Review and approve QC laboratory and contract testing laboratory records and documentation; evaluate data and interpret trends.
Ensure laboratory maintenance and cleaning activities are completed in a timely manner.
Conduct technical investigations of discrepancies, out-of-specification (OOS) results, and unexpected results; support corrective and preventive actions.
Assist with questions during GMP audits and support inspection-related needs.
Support QC testing responsibilities and regulatory requirements pertinent to the laboratory.
Represent QC at operational and cross-functional meetings as needed.