Advanced Pharmaceutical Formulation Expert for Small Molecules

3 weeks ago


Copenhagen, Copenhagen, Denmark Blackswansexist Full time
Senior CMC Specialist Job Description

We are seeking an experienced Senior CMC Specialist to lead small-molecule drug substance projects from candidate selection to commercialization.

Key Responsibilities:
  • Lead drug substance development for small molecule drug projects from candidate selection to late stage and commercialization
  • Drive cross-functional CMC and R&D initiatives, focusing on innovation and excellence in drug substance development
  • E nsure regulatory compliance by preparing and reviewing regulatory documentation (IBs, INDs, CTAs, NDAs)
  • Manage relationships with high-quality CDMOs to deliver exceptional outcomes
Qualifications:
  • M.Sc. or PhD in Chemistry, Pharmacy, or related fields
  • 10-15 years of experience in small molecules late-stage drug development
  • Proven expertise as a Drug Substance Lead, with a strong understanding of ICH guidelines and GMP
  • Strong communication and collaboration skills
Compensation Package:

The estimated annual salary for this role is $140,000 - $160,000, depending on the candidate's qualifications and experience. We also offer a comprehensive benefits package, including health insurance, retirement planning, and opportunities for professional growth and development.



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