MSAT Scientist III, Drug Product
Core
Provide advanced scientific and technical leadership for commercial and clinical drug-product manufacturing processes, serving as a subject-matter expert for formulation, compounding, filtration, filling, and visual inspection.
Role type
Senior IC manufacturing scientist (drug product)
Builds
GMP-compliant drug products for clinical and commercial programs
Domain
Pharmaceutical manufacturing / Gene therapy CDMO
Required skills
GMP compliance, process validation, technology transfer, root-cause analysis, sterile filtration, aseptic filling, formulation and compounding, container-closure systems, single-use manufacturing systems
Preferred skills
Master's degree in pharmaceutical sciences or related field, experience with visual inspection and process characterization
Technologies
GMP documentation systems, process validation protocols
Responsibilities
Lead or support technology transfers of drug-product processes; develop process-validation strategies and author qualification protocols; lead complex deviation investigations and root-cause analyses; develop and maintain process-monitoring and continued process verification programs
Seniority
Senior, hands-on IC