Specialist, QC Cell and Molecular Biology
Quality | Newark, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a QC Specialist to provide scientific technical expertise to the Quality Control Cell and Molecular Biology analytical laboratory. The incumbent will act as Subject matter Expert (SME) for flow cytometry but not limited to potency, cytotoxicity and cell culturing processes. 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/validation/transfer/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. Initially the role will be based in our South San Francisco office for training for 3+ months, and then will be based out of the Newark manufacturing site.
Responsibilities include, but are not limited to:
- Serve as a Subject Matter Expert (SME) for QC test methods focusing primarily on flow cytometry. Demonstrate ability perform flow cytometry analysis (BD FACSLyric preferred).
- Demonstrate expertise in the operation, maintenance and troubleshooting of instruments; trains and qualifies junior laboratory members on test methods.
- 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 flow cytometry methods as needed.
- Support the implementation of reference standards and controls programs for analytical methods. Monitor analytical methods performance and escalate any issue. Prepare control charts for statistical analysis to support new standard qualifications.
- Troubleshoot/optimize analytical methods as needed; identify opportunities to improve efficiency.
- Support Senior Manager 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.
- Provide support in updating SOPs and forms used within the QC CMB unit. Technical writing experience preferred.
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 experience performing flow cytometry is a must.
- 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.
- Ability to multi-task and good adaptability to changing business requirements in a dynamic 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. Able to enjoy a fast-paced environment.
- Proficient in Microsoft Office Suite and Statistical software (JMP).
- Candidates must be authorized to work in the U.S.
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 with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.