Principal Scientist, Drug Substance and Process Science
About Allogene
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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
About The Role
Allogene Therapeutics is seeking Principal Scientist, Cell Starting Material - Process Sciences group within the Process and Product Development organization. This role will be responsible for driving innovation, developing new cell therapy technologies, and implementing robust CAR-T processes to advance Allogene's core technologies in our GMP manufacturing facilities. This individual will be responsible for characterization of cell starting material and developing cell isolation technologies.
Responsibilities
- Lead the design and execution of high-impact Cell Starting Material characterization studies using QbD principles.
- Responsible for execution of characterization activities focused on elucidating dependencies between cell starting material and drug product quality attributes.
- Responsible for evaluating and developing innovative cell isolation technologies.
- Develop and implement technical strategies aligned with departmental and program objectives.
- Drive process understanding and control strategy development to support clinical and commercial manufacturing.
- Serve as a subject matter expert (SME) in cell therapy process sciences, providing scientific and technical leadership.
- Interpret complex datasets and communicate findings to cross-functional teams and leadership.
- Identify process risks and opportunities; propose and implement innovative solutions and process improvements.
- Support the preparation of technical reports, regulatory documents (e.g., IND/BLA sections), and scientific publications.
- Collaborate cross-functionally with R&D, Analytical Sciences, MSAT, Quality, and Regulatory teams to ensure seamless program execution.
- Act as a technical mentor, coaching scientists on study design, data interpretation, and scientific decision-making.
- Remain current with relevant cell therapy, immunology, and bioprocessing literature.
- Perform other duties as assigned.
Position Requirements & Experience
- Ph.D. in Molecular & Cell Biology, Immunology, or a related field with at least 7 years of relevant experience; or MS with at least 10 years of industry experience; or BS with at least 12 years of industry experience.
- Desired expertise in immunology and/or cellular biology.
- Demonstrated expertise in aseptic technique, cell-based assays, and cell culturing.
- Experience in cell isolation and enrichment from a variety of biological sources.
- Experience with cell isolation technologies for cell therapy.
- Experience optimizing cryopreservation media and processes.
- Strong analytical mindset for interrogating datasets.
- Demonstrated experience building robust experimental frameworks to interrogate biological systems, with a strong emphasis on interdependencies among different cell types, process characterization, DOE, and data-driven decision-making.
- Strong understanding of cell therapy manufacturing processes (e.g., gene editing, viral transduction, cell expansion, formulation).
- Proven track record of leading complex technical programs and cross-functional initiatives.
- Strong leadership, mentorship, and cross-functional collaboration skills.
- Strong written and verbal communication skills, including authoring technical documents and presenting to senior leadership.
Pay
The expected salary range for this role is $155,000 - $180,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.