Scientist, Drug Product Process Science (Contractor)

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.

Qualifications

• 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.
• 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.
• 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.
• Candidates must be authorized to work in the U.S.