Manager - New Product Introduction (NPI) and Manufacturing Execution System (MES)
Core
Lead the Downstream New Product Introduction (NPI) and Manufacturing Execution System (MES) team to introduce new products and advanced technologies into the GMP drug substance supply plant.
Role type
Manager, Downstream NPI and MES
Builds
GMP drug substance for clinical trials and commercial production using stainless steel and single-use platforms
Domain
Biotechnology / Bioprocessing / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
team management, GMP operations, New Product Introduction (NPI), drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding), Lean Transformation, Operational Excellence, cross-functional project management, regulatory compliance, electronic batch record (EBR) development
Preferred skills
Chemical/Industrial Engineering/Biology/Biochemistry degree, PAS X and Werum software experience, trend analysis and forecasting, technical writing and presentation, coaching and mentoring, cross-functional collaboration
Technologies
PAS X, Werum
Responsibilities
Manage a team of NPI Specialists and MES Associates for new product introduction and EBR development; Assess team capabilities to meet evolving supply needs; Lead team meetings and drive business process alignment; Coordinate with Process Development, Supply Chain, Engineering, and Quality for new product/technology introductions; Champion Lean Transformation and Operational Excellence initiatives; Ensure regulatory compliance and inspection readiness for the team.
Seniority
Manager, hands-on leadership