USP Manufacturing Specialist
Core
Operate automated production equipment to manufacture recombinant products in a GMP-compliant cleanroom environment.
Role type
Manufacturing Specialist (Upstream Processing)
Builds
Recombinant pharmaceutical products
Domain
Biopharmaceuticals / Upstream Processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, automated equipment operation, process validation, SOP creation, technology transfer support, cleanroom gowning protocols
Preferred skills
Shift work adaptability, on-call availability, hands-on mentality
Technologies
Automated production equipment, cleanroom systems
Responsibilities
Execute day-to-day upstream manufacturing activities, support operational readiness for processing and cleaning, participate in technology transfer and process validation (CVQ/PQ), own work instructions and SOPs, define robust process parameters, support new product introduction
Seniority
Junior to Mid-level, hands-on IC
