CMC Sr. Scientist

Location Oostkamp, Arrondissement of Bruges, West Flanders, Flanders
Discipline: Biotechnology, Pharmaceutical
Job type: Permanent
Contact name: Cherish Becker

Contact email: c.becker@panda-int.com
Job ref: 13256
Published: about 1 month ago
For our partner, a young & dynamic pharmaceutical company that focusses on the development of mRNA-based vaccines. 

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. 

Your responsibilities:

• 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.

Your qualifications:

• 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: c.becker@panda-int.com