Sr. Associate Scientist, Drug Substance-Data 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.

Allogene is seeking a highly motivated Senior Associate Scientist to support the Cell Starting Material - Process Sciences group within the Process and Product development organization. This individual will contribute to the characterization of cell starting material and developing cell isolation technologies, developing and implementing state-of-the-art processing technologies to deliver scalable and robust manufacturing processes.

• Actively contributes to the development and implementation of Cell Starting Material characterization studies using QbD principles to support process understanding, optimization, and characterization activities.
• Applied advanced statistical tools to large and complex data set to advance raw materials and product understanding.
• Support clinical‑scale non‑GMP manufacturing operations for execution of BLA‑enabling process characterization activities.
• Support and contribute to process characterization efforts and continuous improvement initiatives aimed at enhancing CAR‑T manufacturing processes and capabilities (e.g., evaluation of process parameters, materials, closed or disposable systems, and operational workflows).
• 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 relevant cell therapy, immunology, and bioprocessing literature.
• Other duties as assigned

• BS/MS in Molecular & Cell Biology, Immunology with emphasis on data science preferred.
• MS plus at least 2 years of experience or BS with at least 5 years of experience
• A demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology and immunology (required for enhanced product & process understanding).
• Experience in Quality by Desing methodologies and statistical modeling in biologics or cell therapy space is highly preferred.
• Experienced with multivariate data analysis, preferred experience with statistical software (JMP, R-Studio, Python).
• Designed and deployed dashboards for real-time process monitoring, improving data accessibility and decision-making capabilities.
• Experience in flow cytometry is highly preferred.
• Experience with prior Gene & Cell Therapy manufacturing preferred but not required.
• Experience in genetic modification of cells using gene editing and gene delivery technologies preferred but not required.
• Experience with PBMC isolation techniques preferred but not required.
• 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.
• This is a 1-year contract opportunity with the possibility of extension or contract-to-hire.

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which…