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̽���ϼ� is seeking a dedicated and experienced Technical Project Lead CMC for an (Associate) Director role. This role is an exciting opportunity to contribute to a fast-growing biotechnology enterprise. The successful candidate will be a motivated team player with strong organizational skills, ready to deliver tailored Chemistry, Manufacturing, and Control (CMC) packages supporting early development projects.

Responsibilities:

• Collaborate closely with the head of the Pharmaceutical Development Organization.
• Identify and participate in the selection of Contract Manufacturing Organizations (CMOs) for process optimization, formulation work, GMP manufacture, and supply of large molecules.
• Negotiate CDMOs Master Service Agreements.
• Act as the primary contact for third-party CMC vendors for drug product and delivery device development and manufacture.
• Develop CMC plans for all projects.
• Facilitate cross-functional planning of CMC activities across departments and disciplines.
• Provide strong technical leadership and activity management to CDMOs to ensure compliance with cGMP and regulatory requirements.
• Manage efficient flow of information and requests between the program team and the CMC team.
• Conduct regular budget monitoring and contract and vendor management in collaboration with the Project Manager.
• Support the vendor selection process and establishment of contractual frameworks.
• Responsible for supply planning and forecasting procedures for clinical programs.
• Contribute to the compilation of regulatory dossiers in accordance with the overall regulatory strategy.

Key Skills and Requirements:

• MS, PharmD or PhD in biochemistry, biochemical engineering, chemistry, or other discipline within pharmaceutical / biotechnology sciences.
• Experience in pharmaceutical product development, with a focus on managing CMC activities.
• Background in the development of New Biological Entities (NBEs); experience with bio-conjugation, antibody drug conjugates (ACDs) or New Chemical Entities (NCEs) is a significant plus.
• Experience with establishing service contracts and managing external CMOs and contract labs for development work.
• Excellent understanding of CMC processes and insights to early-stage R&D activities.
• Comprehensive understanding of US and EU pharmaceutical regulations and Good Manufacturing Practices (cGMPs).
• Team player spirit and a resourceful and fast learning mindset.
• Excellent networking skills.
• Strategic thinker and strategy developer.

Interested or know someone who might be? Reach out to Antoine Mortiaux using the following:

✉️ a.mortiax@proclinical.com

📞 +33 188 888 168

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

̽���ϼ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽���ϼ� is acting as an Employment Agency in relation to this vacancy.