MSAT Scientist II, 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
Manufacturing Science and Technology (MSAT) Scientist II
Builds
Drug products for clinical and commercial programs
Domain
Pharmaceutical manufacturing (gene therapy/viral vectors)
Required skills
GMP manufacturing principles, process validation, technology transfer, root-cause analysis, sterile filtration, aseptic filling, formulation and compounding, container-closure systems, single-use manufacturing systems, process characterization
Preferred skills
Chemistry, Biochemistry, Chemical Engineering, Biotechnology, Molecular Biology
Technologies
GMP documentation systems, process monitoring tools
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
Mid-level, hands-on IC
