Collaborate with Manufacturing, Process Development, Analytical Development, QC.
Establish internal Drug Product Development capabilities.
Design experiments for stable drug formulations; excipients.
Conduct stability studies under various storage conditions.
Establish scale-down models for DP process design.
Design DP process characterization strategies and enable BLA submission.

🎯 Requirements

PhD in pharma chemistry/biochem/chem Eng/bioeng; 5–8 yrs biologics exp; or MS with 8–11 yrs.
Formulation/DP development; optimization; DOE; CRO management; CDMO tech transfer.
Analytical tools: spectrometry, HPLC, CE, particle sizing.
Fill-finish, clinical compatibility studies, scale-up & tech transfer.
Unit operations scale-down model development and scale-up (filling, filtration, mixing).
Regulatory and quality standards for biopharma manufacturing.

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