MSAT Technical Lead – Drug Substance (Sr Manager)
Core
Lead technical aspects of small molecule drug substance manufacturing, process validation, and lifecycle management for clinical and commercial products.
Role type
Senior Manager, Small Molecule Drug Substance Manufacturing
Builds
Validated manufacturing and analytical processes for rare disease therapies
Domain
Biopharmaceuticals / Small Molecule Drug Substance Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Small molecule drug substance development and manufacturing, Process validation (APR/PQR), Regulatory guidelines and file documentation, External vendor management (CMOs/CDMOs), Cross-functional team leadership, Risk assessment and CAPA management, Technology scouting for process innovation
Preferred skills
Experience with market expansion and variations, Scale-up activities, Cost and yield improvement strategies
Technologies
CMC development tools, Manufacturing execution systems, Regulatory submission platforms
Responsibilities
Serve as SME for small molecule drug substance manufacturing, Lead MSAT projects for process and cost improvement, Review and approve SOPs and manufacturing instructions, Supervise technical studies and validations, Lead product transfer and scale-up activities, Support sourcing and evaluation of new contract manufacturers
Seniority
Senior Manager, hands-on technical leadership