Senior Process Engineer, Drug Substance
Core
Senior Process Engineer supporting Contract Manufacturing Organizations (CMOs) to validate and scale up small molecule Active Pharmaceutical Ingredient (API) manufacturing processes.
Role type
Senior IC process engineer (pharmaceutical manufacturing)
Builds
Industrialized chemical synthesis processes and supply levels for small molecule APIs
Domain
Pharmaceutical manufacturing / Chemical engineering
Required skills
Chemical engineering, cGMP compliance, CMO management, process scale-up, batch record review, risk identification, regulatory documentation analysis
Preferred skills
MS in Chemical Engineering, fine chemical industry experience
Technologies
Scale-up spreadsheets, process manuals, data archiving tools
Responsibilities
Translate lab synthesis processes to industrial instructions, review CMO documentation (batch records, non-conformances), ensure regulatory compliance with Quality Assurance, identify process risks and mitigation plans, conduct person-in-plant (PIP) activities at CMOs
Seniority
Senior, hands-on IC
