Senior CMC Specialist
Black Swans Exist ApS
Copenhagen
Senior CMC Specialist – Small Molecules Drug Development
Lead small molecule drug substance development
Our client is advancing impactful therapies for neuromuscular diseases following recent fundraising success. They are seeking an experienced Senior CMC Specialist to lead small-molecule drug substance projects from candidate selection to commercialization.
This flexible role allows remote work, with occasional visits to Denmark and CDMO in France.
Key Responsibilities:
- Lead drug substance development for small molecule drug projects from candidate selection to late stage and commercialization
- Lead cross-functional CMC and R&D initiatives, innovation and excellence in drug substance development
- Ensure regulatory compliance by preparing and reviewing regulatory documentation (IBs, INDs, CTAs, NDAs)
- Manage CDMO relationships for high-quality outcomes
Qualifications:
- M.Sc. or PhD in Chemistry, Pharmacy, or related fields
- 10-15 years of experience with small molecules late-stage drug development
- Proven experience as a Drug Substance Lead with expertise in ICH guidelines and GMP
- Strong communication and collaboration skills
Ready to make a difference in patients’ lives? Apply today to be part of a mission-driven team!
Contact
If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon. Alternatively apply on LinkedIn here
DANIEL OLSEN
Senior Consultant
BUSINESS DEVELOPMENT
[email protected]
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