Allogene is seeking a Senior/Principal Scientist, Process Development to support the development and characterization of late-stage 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 clinical and commercial manufacturing processes and support successful tech transfer for GMP clinical and commercial manufacturing.
Responsibilities include, but are not limited to:
- Actively contribute to development, implementation, characterization, and successful execution of robust, state-of-the-art CART manufacturing processes.
- Apply Quality by Design and DOE principles to develop a deep understanding of process/ product relationships to define and enable robust, integrated control strategies
- Build and develop capabilities to enable characterization and validation of allogeneic CAR T therapies including the development of robust risk assessments, FMEA, and process characterization plans developed using Design of Experiments and Quality by Design methodology to support BLA and commercialization
- Develop, optimize and validate cell therapy manufacturing process scale-down, models
- Support clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including Tech Transfer to GMP Facilities to ensure successful GMP manufacturing of early and late-stage clinical material.
- Support and 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.
Position Requirements & Experience:
- Ph.D. in Chemical Engineering, Biochemistry, Molecular & Cell Biology, Immunology or the related field with 5+ years or 7+ years (with M.S.) of relevant experience required
- Experience with late-stage Process Development and Process Characterization, including but not limited to, FMEA methodologies, DOE/statistical methods, and BLA authoring
- A demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology, and immunology (required for enhanced product & process understanding)
- Experience with continuous manufacturing processes including operation in upstream genetic modification and bioreactor/WAVE expansion, as well as, formulation/fill and cryopreservation
- Experience in media development, disposable processing technologies, and automation of manufacturing processes
- Experience in genetic modification of cells using gene edit and gene delivery technologies preferred
- Experience in chemical engineering principles including reaction kinetics, reactor design, chemical thermodynamics, heat and mass transport, engineering statistics, modeling, and simulation preferred.
- 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
- Team and project management/leadership experience preferred
- 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.