CMC Project Manager

My client in France seek a CMC Project Manager with a strong analytical background to join their small and dynamic team working on drugs to treat brain disorders.

The company is currently going through a key stage in its development, with two drugs at Phase II, and therefore seeking a highly skilled CMC Project Manager to strengthen their team in Bordeaux.

This person will work on externalized CMC activities, with responsibility for production and analysis of the pharmaceutical product, writing and keeping the regulatory files updated as well as supplying the clinical sites with the pharmaceutical product.

In a stimulating environment, this is a  versatile position directly  reporting to the senior management. As such, you will be responsible for the following tasks:

• Ensure the implementation and monitoring of the pharmaceutical development plan defined with the management team
• Coordinate and monitor the manufacturing and release of pilot and clinical batches of both drug substance and drug product. Analyze, interpret, and verify the consistency of the results with the expected specifications of the products.
• Supervise the improvement of processes, the development of analytical methods and distribution to our external partners (CROs, CMOs)
• Ensure good performance in terms of quality in accordance with regulations (BPF, GMP, USP, EUP). Contribute to ensuring the quality control of products developed and manufactured by subcontractors for future clinical use
• Be the guarantor of the quality and the good realization of the processes developed with international CMOs. Ensure that deadlines and costs are met as defined in advance with the management team.
• Write the regulatory documents required for regulatory submissions (IND and IMPD), registration files as well as technical parts of technical files and product information file
• Carry out a technical and technological monitoring, documentary and bibliographical research
• Participate in the development of the company's patent portfolio by contributing to the filing of new patents

Key Requirements:

• A relevant degree (PharmD, MSc or PhD), with 8-10 years of experience in a similar position in the pharma or biotech environment
• Deep knowledge of manufacturing processes for drug substance and drug product batches in GMP environments
• Solid understanding of pharmaceutical regulations, quality constraints and good laboratory practices
• Good team skills and ability to work in an interdisciplinary and international environment.
• Independence and responsibility in decision making and task execution in project management of pharmaceutical development.
• Excellent oral and writing communication skills in both English and French

If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441273 952176, or apply with your CV to arrange a confidential discussion.

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