Head of Pharmaceutical Development - CMC
Nonstop is currently looking for a Head of Pharmaceutical Development on behalf of a growing company launching its lead product in the field of Molecular Nuclear medicine. This recent success has also led to a significant staff increase across Europe for the last 2 years.
Reporting to the Global head of R&D, you will be in charge of the overall operational management and oversight of pharmaceutical development. Furthermore, you will work closely with all R&D members as well as Regulatory Affairs, Project Management and the Group Responsible Pharmacist, to coordinate and ensure the successful completion of the pharmaceutical development activities within the agreed timelines and budget, and in compliance with the required quality, Good Manufacturing Practice and ICH Guidelines.
- PharmD or PhD in Pharmaceutical Sciences, with comprehensive knowledge in injectable products manufacturing.
- Industry experience in (radio) pharmaceutical products development, including radiopharmaceutical kits.
- Hands-on knowledge of analytical chemistry and injectable formulation development, including analytical method development, manufacturing processes and technology transfer.
- Track record in CMC documentation review and interactions with regulatory authorities for relevant parts of regulatory submission related to pharmaceutical development, including IMPD, IND, CTA, MAA and NDA. -
- Highly developed management and communication skills, with experience in working in a matrix organisation.
- Professional proficiency in both spoken and written English.
If you are interested in receiving more information, please contact Chloé Khatcherian on 0033 1 76 75 33 40 or send your CV to firstname.lastname@example.org