Drug Substance MSAT Scientist II
Core
Perform manufacturing process development for injectable drug substances, executing technology transfer and scale-up activities to commercial lines.
Role type
Drug Substance MSAT Scientist II (Process Development)
Builds
Injectable drug substance formulations and processes for commercial manufacturing
Domain
Pharmaceutical / Biopharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Experimental design, formulation development, technology transfer, process validation, GMP compliance, statistical data analysis, change control management, technical documentation
Preferred skills
Experience in CMO or pharmaceutical product development, knowledge of single-use systems and equipment design
Technologies
None explicitly listed beyond general pharmaceutical equipment and instrumentation
Responsibilities
Complete studies, tech transfer, commercial scale-up and support process validation; Represent the organization on internal technical discussions; Actively participate in problem solving and project results for formulations, equipment and processes; Write/revise work orders, protocols, and reports; Lead projects with moderate supervision to meet timeline and goals; Support manufacturing operations, change controls, and investigations as SME
Seniority
Mid-level individual contributor (2+ years experience or Master's degree)