Senior Principal Scientist (all genders) - External API Development for New Chemical Entities
Core
Design, develop, and enable synthetic routes for new chemical entities (NCEs) to evolve into robust API manufacturing processes in partnership with external CDMO networks.
Role type
Senior Principal Scientist (Drug Substance Lead)
Builds
Scalable and sustainable API manufacturing processes for preclinical and clinical phases
Domain
Pharmaceutical industry, synthetic chemistry, CMC development
Required skills
Synthetic chemistry, process chemistry, CMC development, external partner management, regulatory filings, control strategies, troubleshooting
Preferred skills
Peptide CMC development, steering external partners (CROs/CDMOs), cross-functional teamwork
Technologies
GLP/GMP, analytical techniques, regulatory filings (IND/IMPD)
Responsibilities
Design and optimize synthetic routes for new APIs; represent Drug Substance in global CMC teams; guide route design at external CDMOs; oversee external API campaigns for toxicology and clinical trials; steer process transfers; contribute to control strategies and regulatory filings; provide CMC assessments for in-licensing opportunities
Seniority
Senior, hands-on IC with strategic leadership