We are looking for an enthusiastic scientist for CMC project management to drive the company from Lab to Industry!
You'll hold a key position in the company and will be contributing greatly to the overall success of the company.
• The development and execution of sound strategies for manufacturing of our vaccines.
• Vendor Management: Interact with contract manufacturing organizations (CMOs) to complete preclinical, IND-enabling and Phase I activities. Ensure vendors stay on-task and complete contracted work in a timely manner. Integrate deliverables and dependencies between vendors seamlessly.
• All aspects of drug substance and product, including development and manufacturing.
• Project management
• Format, edit, coordinate, and review regulatory documentation for inclusion in INDs, CTAs, and other worldwide submissions.
• You have a PhD in the life or physical sciences, e.g. biochemistry, microbiology, biotechnology, chemistry, chemical engineering, etc.
• 5+ years of relevant experience with a proven track record of successful CMC project management
• Experience with outsourcing of manufacturing work to CMOs/CDMOs
• Experience with cGMP and ICH regulations, working in a government regulated environment (EMA, FDA, FAGG, …)
• Experience in the field of mRNA/vaccines will be considered as a strong advantage
Is this you? Call me: +32 28 08 8622 or +31 20 204 4502
Or feel free to submit your CV to Cherish Becker at: email@example.com