Drug Product Leader

CMC Leader – Drug Product (Solids) Development | Contract |

We’re seeking an experienced CMC Leader with deep expertise in solid oral dosage forms to lead drug product development activities for a late-phase small molecule program

Key Responsibilities

• Lead CMC strategy and execution for a late-stage oral solid drug product (capsule-to-tablet transition).
• Represent CMC in cross-functional project teams and align on development and clinical supply plans.
• Oversee external vendors for formulation development, scale-up, and GMP manufacturing.
• Review and approve technical documentation (development reports, batch records, protocols).
• Monitor and interpret stability data; adjust formulation or shelf-life strategy as needed.
• Prepare and archive regulatory documentation; support responses to Health Authority queries.
• Contribute to due diligence activities as required.

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