Director, MSAT API Lead
Core
Owns end-to-end technical oversight of API supply performance and continuity across external manufacturing partners (CMOs), establishing technical governance and managing tech transfers.
Role type
Director, MSAT API Lead (Process Engineering)
Builds
API supply continuity and robustness for metabolic disease therapeutics
Domain
Biopharmaceuticals / API Manufacturing / CMO Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
API technical governance, process monitoring, yield/cycle time/reliability improvement, tech transfer readiness planning, deviation/investigation/CAPA leadership, change impact assessment, CMO partner management
Preferred skills
Pharmaceutical/biotech GMP manufacturing experience, CMO audit/inspection support, multi-product/multi-CMO governance leadership
Technologies
None explicitly stated
Responsibilities
Define CMO technical governance models and escalation triggers, drive process robustness improvements, coordinate tech transfer readiness with CMC/Quality, lead technical input to deviations and CAPAs, assess change impacts on control strategy, produce technical governance packs and risk briefs
Seniority
Director, strategic oversight & cross-functional leadership
