Senior Manager/Associate Director, External Testing
Quality | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
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™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, 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 looking for a seasoned, broadly trained scientist and manager to oversee the external quality Control (QC) testing laboratory operations supporting the CAR T products’ clinical and commercial manufacturing. Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The candidate will support the QC organization in ensuring the readiness of QC contract testing laboratories (CTL) for the seamless execution of release and stability testing within agreed upon timeline to meet clinical demands according to plan and budget. The candidate will support the QC head and partner with External Quality Assurance (QA), as well as external partners in defining laboratory systems and processes for the compliant operation of this external QC laboratory network, defining and tracking key performance indicators, and resolving issues as they arise. The candidate will maintain strong connections with the internal Allogene QC laboratories ensuring alignment on requirements for methods, critical reagents, and instruments as needed. The role will entail operating in a fast-paced, highly dynamic environment with company work partnerships including both internal and external stakeholders. This role will report to the Head of QC.
Responsibilities include, but are not limited to:
- Provides leadership, management and technical oversight for the successful execution of release and stability testing at various CTL within agreed upon turnaround-time (TAT) and within budget. Responsible for the review of CTL data, ensuring that they are maintained in compliance with regulatory and Allogene’s requirements.
- Coordinates with Allogene laboratory heads and CTL the maintenance and management of critical laboratory reagents, standards and controls ensuring uninterrupted operation.
- Establishes processes to trend methods performance at CTL over time. Align with internal Allogene laboratories on control materials and performance as needed.
- Ensures, where applicable, alignment on instrument requirements/equivalency between Allogene and CTL.
- Keeps current with revisions to test methods at Allogene and CTL. Where applicable, revises methods and related documentation per established change management procedures at Allogene and CTL.
- Aligns and coordinates with stability manager on stability samples testing to ensure timely execution and adherence to stability studies schedules.
- Manages performance of CTL by tracking and ensuring established KPI are met. Escalates CTL performance issues to management in a timely manner.
- Actively manage CTL associated costs and ensure compliance with budget goals.
- Oversees validation/verification of methods for CAR T products and raw materials at CTL ensuring compliance with regulatory requirements. Provides direction and guidance to authors of method validations/verifications protocols and reports and evaluate data generated from these activities. Investigates and oversees validation exception reports where needed.
- In collaboration with Allogene laboratory heads and Head of Infrastructure Support and Methods Life Cycle, oversees technical transfer of CAR T and raw materials methods to and from CTL in line with regulatory requirements and per project timeline and budget. Establishes new and improves existing processes for transfer ensuring cross functional alignment with stakeholders across sites
- Provides technical guidance and management support for testing related nonconformance events, associated corrective and preventative actions and change control. Collaborates effectively with Allogene External QA to manage the initiation, evaluation, and closure of nonconformance events and CAPA implementation plans at CTL.
- Investigates unexpected/Out of Specification/Out of Trend test results. Helps define investigation/re-test plans, where applicable. Collaborates effectively with Allogene’s and the CTL’s QA representatives to manage the initiation, investigation, and compliant closure of these events.
- Authors and reviews technical registration documents and other sections of regulatory submissions pertaining to methods executed at CTL.
- Supports Allogene inspections and audits at CTL sites as well as internal Allogene regulatory inspections as the CTL liaison. Supports external QA in ensuring CTL are ready for GMP and pre-approval inspections (PAI).
- Collaborates cross functionally and builds relationships with external CTL and within Allogene QC, QA, Regulatory Affairs, Development, Manufacturing and Supply Chain to meet target milestones. Be able to negotiate, influence, and work in a matrix environment and across sites.
- Manages multiple projects, set priorities, and work in a fast-paced environment.
- Able to negotiate, influence, and work in a matrix environment.
- Other duties as assigned
Position Requirements & Experience:
- M.S./B.S. Degree, Ph.D. is a plus.
- Minimum 6-8 years of analytical development/QC laboratory experience in biotechnology with 2-4 years in a management role.
- Experience with analytical and biochemical methods including but not limited to cell-based assays/techniques including FACS analysis, potency testing, and immunofluorescence, molecular biology methodologies including but not limited to DNA, RNA manipulation and PCR, ELISA/HTRF, as well as electrophoresis/western blot analysis. Experience with HPLC systems is a plus.
- Experience with microbiological tests including compendial sterility testing, mycoplasma, endotoxin and viral testing.
- Strong understanding of GMP requirements and QC systems
- Experience with method development, validation and transfer
- Experience in dealing with regulatory agencies, supporting GMP and PAI inspections as well as experience with regulatory filings.
- Strong leadership ability, interpersonal, communication, and influencing skills required.
- Highly collaborative with the proven ability to work in a cross-functional team.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Expected to travel 15-20% of time.
- Candidates must be authorized to work in the U.S.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably
As an equal opportunity employer, Allogene Inc. 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.