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Drug Product Leader
Planet PharmaBelgium, Belgium7 dagen geleden
FunctieomschrijvingMSc 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.
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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Leader • Belgium, Belgium