Job Description
About the role:Allogene is seeking a highly determined, results-oriented, self-starter who demonstrates personal accountability for outcomes and is motivated by increasing levels of responsibility, to join a dynamic team responsible for successful development and characterization of clinical-scale manufacturing of Allogeneic Chimeric Antigen Receptor T-cell therapies (Allo CAR T™). The successful candidate will help to support appropriate analytical methods for the characterization, release and stability testing of CAR-T products. This position will also contribute to the development of novel technologies and approaches to meet future CART analytical needs and work in close collaboration with key stakeholders, including the CART Research and Process Development groups.
Responsibilities include, but are not limited to:- Actively contribute to successful and efficient execution of robust, state-of-the-art multicolor flow cytometry methods, cell-based potency assays and molecular assays for the characterization of CAR T manufacturing processes and products
- Provide analytical support for the development and execution of Process Characterization and BLA-enabling activities, including qualification of in-process and release methods and tech transfer internally and externally in support of GMP manufacturing and release of clinical material.
- Contribute to project technical teams to ensure effective communication at all levels. Collaborate effectively to ensure productive interactions with all stakeholder groups.
- Demonstrate strong accountability, organizational and interpersonal skills, and apply sound scientific and technical experience.
- Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports which support regulatory filings.
- Present data/ strategy to scientists and management internally.Lead, train, and supervise a small team of scientists and junior analysts. Coordinate daily laboratory activities, balance workloads, and ensure project deadlines are met.
- Ensure accuracy and compliance in executing routine and non-routine testing. Audit analytical results and troubleshoot complex assay or instrument issues.
Position Requirements & Experience:- PhD in Immunology, Cell Biology, or related field with at least 2 years of experience or Bachelors/Masters degree in Immunology, Cell Biology, or related field with the equivalent industry experience.
- Laboratory experience in a variety of analytical methods for the characterization and release of cell-based therapies, include, but not limited to: multi-parametric flow cytometry-based assays for characterization/ release/ stability testing, cell-based cytotoxicity assays, cell-based proliferation assays, cytokine measurements and molecular assays.
- Hands-on expertise in processing of human peripheral blood mononuclear cells and the isolation and analysis of CAR-T cells and T cell subsets and subpopulations.
- Proficiency in Spotfire or R is a plus.
- Familiarity with cGMPs and relevant Regulatory Guidance documents.
- Strong interpersonal skills including verbal and written communication to work effectively within a collaborative work environment as an individual contributor and as a team member
- 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 $135,000 - $160,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
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