Drug Product Development and CMC Leader
Drug Product Development and CMC Leader
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Job Description
General information
Publication date
02/07/2025Category
OPERATIONS - CONSULTING
Job title
Drug Product Development and CMC Leader
Contract
Permanent contract
Job description
About the Role
As Drug Product Development (DP) Leader within the CMC team you will provide drug product development expertise for the further development of the project. You will manage the clinical bulk supply for a late-stage small molecule program (currently Phase 2 capsule; Phase 3 tablet development in progress). The development and manufacturing activities are outsourced to external service providers (ESPs). In this key role you will contribute your deep pharmaceutical expertiseespecially in solid dosage form developmentto drive the success of the project.
Key Responsibilities
- Lead the development and supply of drug product materials in line with the overall CMC and clinical strategy
- Develop CMC strategy
- Represent CMC within the project team
- Align on strategy planning activities and ensure effective coordination of CMC team
- Manage the CMC budget and report updates to the project team
- Oversee the (bulk) manufacturing of development batches and GMP batches for clinical purposes
- Analyze formulation and process data and adapt as needed
- Monitor capsule and tablet stability studies refining plans based on findings
- Prepare review and approve CMC documentation for regulatory submissions
- Manage and liaise with ESPs performing development and manufacturing tasks
- Review and archive key documentation from ESPs (e.g. protocols batch records reports)
- Collaborate with Quality & Compliance teams to ensure ESPs adhere to cGMP standards
- Keep the Product Specification File up to date
- Ensure compliance with internal procedures and procedures and complete mandatory trainings
- Provide input for due diligence processes when requested
Business Industry
Life sciences
Profile
- Master or PhD in pharmaceutical sciences chemistry bio-engineering or equivalent through experience
- Minimum of 10 years of relevant experience in a drug product development role
- Expertise in solid formulation development and experience working with CROs
- Proven track record in cross-functional collaboration and technical leadership
- Fluent in English both written and spoken
- Strong organizational interpersonal and communication skills
- Pragmatic hands-on and solution-oriented
Job location
Europe Belgium
Location
Candidate criteria
Level of experience
5 to 10 years
Employment Type
Full-Time
