Scientist, Drug Product Process Science (Contractor)

Allogene Therapeutics • South San Francisco, CA

8d • $50 - $58 • Onsite

About The Position

Allogene Therapeutics is seeking a highly motivated individual for the role of Scientist, Drug Product Process Science (Contractor) to join the Process and Product Development department. The successful candidate will design, execute and contribute to the activities related to process characterization for BLA readiness, as well as drug product formulation, fill/finish, cryopreservation, dosage administration studies of clinical-scale manufacturing processes in support of AlloCAR T™ clinical supply and commercialization.

Requirements

• M.S. in Pharmaceutics, Immunology, biomedical engineering, or related discipline with 5+ years of industry experience (or BS with 8+ years).
• Experience supporting development, characterization, scale-up, or commercial manufacture of drug product processes, including formulation, fill/finish, cryopreservation, storage, or administration of biologics or cell therapy products.
• Working knowledge of cell biology, aseptic cell culture and cell-based analytical methods.
• Experience applying Design of Experiments (DOE), statistical analysis, and data visualization tools (JMP, Spotfire, or equivalent) to process development or characterization studies.
• Strong technical writing skills and experience preparing technical reports, protocols, study plans, and development documentation.
• 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.

Nice To Haves

• Experience with electronic data systems and ELNs (e.g., Benchling or similar platforms) for experimental documentation, data analysis, and collaboration is preferred.
• Familiarity with cGMP manufacturing and regulatory expectations for biologics or cell therapy products is a plus.

Responsibilities

• Design and execute studies to contribute to drug product process characterization activities to enable BLA submission.
• Establish and qualify representative scale down models (SDMs) to support drug product process characterization studies.
• Participate in cross-functional process FMEA activities and contribute to process characterization design.
• Apply statistical tools and Design of Experiments (DOE) methodologies to evaluate process robustness and characterize process parameters.
• Develop and execute in-use compatibility studies with analytical science team to deliver timely results, and collaborate with Clin Ops on development, implementation, and management of DAI and IPM
• Provide support for drug product process technology transfer, trouble shooting and serve as person-in-plant as needed
• Actively participate in cross-functional activities with PD, AD, MSAT, and QC teams
• Thorough and timely documentation in electronic laboratory notebooks, data summarization and analysis.
• Author technical development reports, PSDs, Batch Records and DP-related sections in regulatory filings.

Benefits

• annual performance bonus
• equity
• health insurance
• generous time off (including 2 annual holiday company-wide shutdowns)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior