Specialist Manufacturing-New Product Introduction (NPI)
Core
Bridge between GMP manufacturing teams and process development scientific groups to introduce new drug substances and advanced technologies into the plant.
Role type
Specialist Manufacturing, New Product Introduction (NPI)
Builds
New Drug Substance products and advanced technologies for Amgen's biotech manufacturing plant
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
GMP operations, downstream drug substance processing, upstream processing, electronic batch record editing, Lean transformation, operational excellence, change control management, technical writing, troubleshooting, root cause analysis (RCA), CAPA development
Preferred skills
Chemical/Industrial Engineering degree, PAS X and Werum software proficiency, cross-functional project management, trend analysis and forecasting, coaching and mentoring, chromatography, filtration, buffer compounding, cell culture, harvest
Technologies
PAS X, Werum
Responsibilities
Coordinate with Supply Chain, Planning, Facilities, Engineering, Quality, and Manufacturing to introduce new products; Lead or participate in projects ensuring accurate production documents; Support troubleshooting, problem solving, and RCAs; Champion Lean Transformation and OE initiatives; Collaborate with Regulatory and Quality on change control and audit findings; Generate and edit electronic and paper process documents.
Seniority
Specialist, hands-on IC