Senior Drug Substance Scientist

• Evaluate new technologies and approaches for DS manufacturing
• Drive DS process development with internal process laboratory support and CMOs to deliver preclinical, Phase 1 and Phase 2 supply, and mature processes toward Phase 3 in collaboration with late stage colleagues
• Key player in the collaboration with DS CMOs, including day-to-day communication and oversight, follow-up on project timelines, documentation review, knowledge transfer, and scoping of process development
• Contribute to risk assessments, critical process parameters (CPP), and scoping process development at the CMO
• Represent DS in cross-functional CMC teams and drive scientific and strategic input to clinical trial applications and regulatory interactions in collaboration with Regulatory Affairs

• M.Sc. or PhD within chemistry, biochemistry, pharmaceutical sciences, or another relevant field
• +5 years of experience from the pharmaceutical industry
• Experience from DS process chemistry laboratories and process development activities
• Experience with solid-phase peptide synthesis and contributing to process optimization
• Experience with outsourcing of DS/API production at CMOs, including technical oversight and review of CMO documentation
• Experience with regulatory aspects of CMC work and Good Manufacturing Practice (GMP)
• Strong oral and written communication skills in English

Experience with other fields of synthetic chemistry such as antibody-drug conjugates, liquid-phase peptide synthesis, and small molecules