Job Description
About the role:Allogene Therapeutics is seeking a highly motivated individual for the role of Principal Scientist, Drug Product Process Science to join the Process and Product Development department. The successful candidate will play a critical role in drug product process characterization and BLA readiness for allogeneic CAR-T therapies, including but not limited to process characterization design and execution, and regulatory-ready documentation in support of BLA-enabling and BLA submission activities, and will work closely with cross-functional partners across MSAT, Quality, Regulatory, Analytical Sciences, and Clinical Operations.
Responsibilities include, but are not limited to:- Design Drug Product process characterization strategies using Design of Experiment (DOE); Lead the design, execution, analysis and documentation of Drug Product process characterization studies to enable BLA submission.
- Establish and qualify representative scale down models (SDMs) in support of drug product process design and process characterization.
- Develop and execute in-use compatibility studies and collaborate with Clin Ops on the development, implementation, and management of DAI and IPM
- Lead the development and continuous improvement of DP data organization, analysis and visual workflows to enable efficient protocol execution and support regulatory readiness
- Provide DP technical leadership for large scale manufacturing runs, including "person-in-plant" support as needed.
- Ensure timely, complete, and inspection-ready documentation, including protocols, reports, ELN records, and regulatory content.
- Author and review BLA-enabling technical documents, including risk assessments, protocols, development reports, process descriptions, control strategy/validation/PPQ-supporting documentation, and Module 3 DP sections (IND and BLA).
- Contribute to the establishment of DP best practices and mentoring of future DP hires as the team scales.
Position Requirements & Qualifications:- Ph.D. in Pharmaceutics, Immunology, biomedical engineering, or related discipline with at least 7 years of industry experience; or MS with at least 10 years of industry experience; or BS with at least 12 years of industry experience.
- Experience working in the pharmaceutical or biotechnology industry that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers, statistical process control (SPC), and statistical design and analysis of experiments
- Hands-on experience developing drug product processes using Quality-by-Design (QbD) principles for autologous and/or allogeneic cell therapies, preferably including late-stage or BLA-enabling programs.
- Experience designing and executing process characterization and/or PPQ-related studies for biological or cell therapy products.
- Prior contribution to regulatory submissions (e.g., IND, BLA) is highly preferred.
- Experience with electronic data systems and ELNs (e.g., Benchling or similar platforms) for experimental documentation, data analysis, and collaboration is preferred.
- Experience in pharmaceutical development is a plus.
- Demonstrated ability to operate effectively in high-intensity execution phases with overlapping protocols, data analysis, and reporting timelines.
- Strong background in immunology, cell biology, aseptic primary cell culture and cell-based assays.
- Proficiency in statistical software (e.g. JMP, or similar)
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Ability to work independently in a fast-paced startup environment as well as work collaboratively in a highly interactive team environment.
- Candidates must be authorized to work in the U.S.
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. 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.
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