Sr Process Engineer/Process Engineer, MSAT
Process and Product Development | South San Francisco, CA | Full Time
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 seeking a Senior Process Engineer/Process Engineer to join our Manufacturing Science and Technology group and contribute to the commercialization of allogenic CAR T therapies. This individual will lead/support various aspects of technology transfer, validation, and manufacturing support activities. He/she will work closely with internal and external partners to ensure the development and execution of a master validation plan, and the subsequent execution of process performance qualification (PPQ) runs and continuous verification activities.
Responsibilities include, but are not limited to:
- Support technology transfer, trouble-shooting and continuous improvement of GMP manufacturing outcomes
- Support development of capabilities to enable technology transfer and scale-up of cellular based therapies
- Translate laboratory/pilot scale cell therapy manufacturing technologies and processes to clinical and commercial manufacturing scale and ensure reliable and compliant supply
- Implement and evolve integrated control strategy for allogeneic CAR-T therapies
- Develop sophisticated process modeling and risk management capabilities to guide facility design and facility fit
- Provide reliable process requirement inputs to support business case and capital project decision-making
- Manage strategic partnerships with external manufacturers (CMOs) of CAR-T therapies
- Ensure technical strong and compliant technical justifications for manufacturing deviations
- Other duties as assigned
Position Requirements & Experience:
- PhD in a scientific discipline (Chemical Engineering, Life Sciences or related), MS 4+ years relevant experience, or bachelors with 6+ years of relevant experience
- Prior experience with technology transfer of biological products and/or validation required. Cell and gene therapy experience preferred
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Ability to work both 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.