Head of CMC
HEAD OF CMC
The Head of CMC is responsible for all CMC-related technical operations activities, including overall management of process and product development, selection and oversight of the pharmaceutical supply chain, technology transfer, manufacturing and supply of clinical trial material. You ensure the Quality and RA compliance of CMC-related activities with the corporate policies. You report directly to the CEO and are part of the Executive management.
Your responsibilities :
- Responsible for overall management of product and process development.
- Manage all drug substance and drug product activities from technology transfer to clinical supplies for clinical studies.
- Select and manage CMOs for process optimization, cGMP manufacture, supply, testing, release and distribution of Drug Substance (API) and Drug Product (DP).
- Manage the non-GMP productions and associated analytical development activities.
- Delivery of robust, scalable and cost-effective manufacturing routes and drugs product formulations that meet or exceed the target clinical profile.
- Projection of API and DP needs and costs for preclinical and clinical programs and associated budget.
- Management of supply chain and logistics insupport of clinical studies.
- In coordination with QA, implement stage appropriate analytical methods and protocols and ensure that all contract manufacturing and testing services providers are using systems and processes in compliance with all relevant regulatory standars.
- Execute plans for the validation and registration of API and DP as required by cGMP, ICH and FDA regulations, in coordination with QA and RA.
- Represent the company as the CMC expert before U.S. and European Regulatory authorities.
- Oversight of the preparation, review and edition of cGMP batch records and CMC regulatory and quality documents.
- Responsible for overseeing Technology Transfert to manufacturing contractors or internal manufacturing facilities.
- Train, monitor and mentor direct reports on Biomanufacturing activities.
- Identify aeras of efficiency gains across programs and implement within group.
- Manage and oversee continuous process improvement initiatives.
- Coordinate with management to prioritize and schedule activities to meet deadlines.
- Manage, supervise, execute and document product and process development activities.
- Provides regulatory enabling services.
Your profile :
- PhD in Life Science with at least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment.
- Relevant expertise in lab techniques focused on protein expression, isolation and analysis.
- Experienced in managing CMOs for the manufacture of cGMP APIs and DP.
- Experienced in cGMP manufacturing and IND, CTA and NDA regulatory filings.
- Thorough knowledge of relevant FDA and EMEA regulations.
- Experience with implementing technical, strategic and operational plans.
- Excellent communication and organizational skills.
- Ability to identify and resolve critical issues.
- Fluent in French and English.
Our clients offer an exciting role in a dynamic team as well as a chance to further develop your skills. A permanent contract with an attractive salary package and extra-legal benefits (insurance, lunch vouchers, etc.).
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