(Associate) Director, Technical Project Lead CMC

Highly Competitive
  1. Permanent
  2. Project Engineering
  3. Switzerland
Basel, Switzerland
Posting date: 14 Jun 2024
60921

Proclinical 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.

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

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