Associate Scientific Director
Core
Technical leader responsible for assessing, de-risking, and enabling the successful scale-up of clinical drug substance manufacturing processes from laboratory scale through pilot plant and manufacturing scale implementation.
Role type
Associate Director, Process Scale-Up & Manufacturing Readiness
Builds
Reliable, safe, and executable manufacturing processes at scale for small molecule drugs
Domain
Pharmaceutical manufacturing (small molecules, ADCs, oligonucleotides, peptides, radiopharmaceuticals)
Required skills
Chemical engineering expertise, process scale-up, GMP manufacturing operations, process safety, technology transfer, risk management, cross-functional collaboration
Preferred skills
Experience with ADCs, oligonucleotides, peptides, radiopharmaceuticals, clinical to commercial manufacturing transition
Technologies
cGMP systems, pilot plant equipment, manufacturing unit operations
Responsibilities
Lead technology transfer and on-site support at external CDMO sites, lead manufacturing readiness assessments, influence manufacturing strategies across a large portfolio, serve as SME for chemical manufacturing operations, apply process safety and risk management principles, represent engineering in cross-functional forums
Seniority
Senior, hands-on IC with strategic influence