Director, DP MSAT
Core
Define and lead Manufacturing Sciences and Technology strategy for biological drug products, serving as senior technical authority for contract drug product and fill-finish manufacturing.
Role type
Director, Drug Product Manufacturing Sciences and Technology (MSAT)
Builds
Biological drug products (monoclonal and bispecific antibodies) for clinical development and licensure
Domain
Biopharmaceuticals / Biologics / Contract Manufacturing
Required skills
Monoclonal and bispecific antibody manufacturing, aseptic fill-finish operations, cGMP compliance, technology transfer, CDMO management, process validation, regulatory filings, root cause analysis, equipment qualification
Preferred skills
Device and combination product experience, late-stage biologics licensure, pre-formulation and formulation methods
Technologies
cGMP batch documentation systems, process characterization tools, regulatory submission platforms
Responsibilities
Guide external manufacturing partners on new product introductions and technology transfers; approve CDMO cGMP batch documentation; drive process performance improvement; author technical reports for licensure; develop sampling plans for batch release and stability; lead equipment selection and qualification; oversee CDMO investigations and CAPA implementation; define technical requirements for raw materials and equipment; contribute to regulatory filings.
Seniority
Director, strategic leadership with hands-on technical authority