Sr Prin. Sci/Principal Sci, Process Development -Drug Substance
Process and Product Development | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, 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/Principal Scientist, Process Development to support the development and characterization of clinical-scale manufacturing processes for Allogene’s CART 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 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 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 allogenic CAR T therapies including development of robust risk assessments and characterization plans developed using Design of Experiments and Quality by Design methodology to support BLA and commercialization
- Develop and optimize cell therapy manufacturing process scale down models.
- Support clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including Tech Transfer to CMO and support of successful GMP manufacturing of clinical material.
- Support and contribute to relevant and impactful innovation programs to enhance CART 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 prior Gene & Cell Therapy manufacturing preferred
- A demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology and immunology (required for enhanced product & process understanding).
- Experience in genetic modification of cells using gene edit and gene delivery technologies.
- Experience with continuous manufacturing processes including operation in upstream genetic modification and bioreactor/WAVE expansion, as well as downstream purification/separation, formulation/fill and cryopreservation.
- Experience in media development, disposable processing technologies and automation of manufacturing processes.
- Excellent knowledge of chemical engineering principles including: reaction kinetics, reactor design, chemical thermodynamics, heat and mass transport, engineering statistics, modeling and simulation.
- Laboratory experience in a variety of analytical methods for the characterization and release of cell-based therapies, especially multi-parametric flow cytometry-based assays for characterization/ release/ stability testing preferred.
- 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 preferred.
- Proficiency in data analysis and interpretation using FlowJo and FACS Diva 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.
- 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 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.