Senior Manager, Process Chemistry

Role: Senior Manager, Process Chemistry on the API Development team, responsible for managing API/intermediate/RSM manufacturing at Insmed’s CMOs, including tech transfer, process optimization, and validation. Responsibilities: oversee scale-up, process improvements, and provide technical support as SME; review quality documentation; contribute to process refinement for clinical and commercial manufacturing. Requirements: PhD or Master’s with 3+ years in API process development/execution; experience with pharmaceutical manufacturing technology, working with CMO operations, and regulatory compliance. High-Value: expertise in NCE synthesis, physical organic chemistry, CMC drug substance documentation, validation principles, and cGMP standards; preferred experience in marketed products across US, EU, JP. Work setup: fully remote with occasional domestic/international travel (~10%).