API Lead
Core
Lead the development and manufacturing of APIs, precursors, and key materials at external CMOs from early development through commercialization.
Role type
Senior IC pharmaceutical process development and manufacturing lead
Builds
Robust and compliant API manufacturing solutions for medical imaging agents
Domain
Pharmaceutical manufacturing / Synthetic chemistry
Required skills
Synthetic chemistry, GMP, regulatory CMC, process development, scale-up, technology transfer, CMO management, API characterization, impurity control, CMC documentation
Preferred skills
Stakeholder management, cross-functional collaboration, risk management
Technologies
GMP, ICH guidelines, CMC documentation
Responsibilities
Lead API development and manufacturing at external CMOs; Act as primary technical interface between internal teams and external partners; Define development strategies and oversee process optimization; Assess and onboard CMOs and suppliers; Lead technical and quality challenges; Define impurity-control strategies; Prepare CMC documentation for regulatory submissions.
Seniority
Senior, hands-on IC