Scientist/Senior Associate Scientist, Process Development
Process and Product Development | 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 a greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a Scientist or Senior Associate Scientist to support the development and characterization of clinical-scale manufacturing processes for Allogene’s CAR T therapies.
This individual will contribute to the development, implementation, and characterization of state-of-the-art processing technologies to deliver scalable and robust manufacturing processes and support successful tech transfer for GMP manufacturing and release at a CMO. This position will also contribute to the development of novel technologies and approaches to meet future CAR T manufacturing needs.
- Actively contribute to development, implementation, characterization and successful execution of robust, state-of-the-art CART manufacturing processes.
- Support clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including Tech Transfer to CMO and support of successful GMP manufacturing of clinical material
- Contribute to relevant and impactful innovation programs to enhance CAR T manufacturing technologies/ capabilities and work-processes (such as alternate transfection/ cell engineering strategies, media development, disposable/ closed production systems, and automation), aligned with emerging business drivers and regulatory expectations.
- Contribute to Project Technical Teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups
- Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.
- Present data/strategy to scientists (and management) in internal venues (technical meetings, Project Team meetings) as appropriate.
- Remain current with the process engineering and chemistry literature. May collaborate and author external publications and present research at external conferences
- Ph.D., MS or BS in Chemical Engineering, Biochemistry, Molecular & Cell Biology, Immunology or the related field with 0+ years (with Ph.D.), 2+ years (with MS) or 5+ years (with BS) of relevant experience required.
- Experience with prior Gene & Cell Therapy manufacturing is preferred, but not required.
- A demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology, and immunology (required for enhanced product & process understanding).
- Experience in flow cytometry for T cells characterization is preferred, but not required.
- Experience in FMEA, process characterization, and DOE methodologies in biologics or cell therapy space preferred.
- Experience in genetic modification of cells using gene edit and gene delivery technologies is preferred, but not required.
- Experience with continuous manufacturing processes including operation in upstream genetic modification and bioreactor/WAVE expansion, and cryopreservation.
- Ability to work in a fast-paced, startup environment.
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
- 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.
- Candidates must be authorized to work in the U.S.
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.