Job Title: Senior CMC Specialist – Small Molecules Drug Development

Location: Remote (Europe), with occasional travel to Denmark

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!