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Drug Product Leader

Drug Product Leader

Planet PharmaBelgium, Belgium
4 dagen geleden
Functieomschrijving

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.

Your Profile

  • MSc or PhD in Pharmaceutical Sciences, Chemistry, Bioengineering, or related field.
  • 6+ years of experience in drug product development, with strong expertise in solid oral formulations .
  • Proven track record in late-stage development and external vendor management .
  • Strong communicator with experience in cross-functional collaboration and regulatory documentation.
  • Hands-on, pragmatic, and quality-focused.
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