Manager - New Product Introduction (NPI) and Manufacturing Execution System (MES)
Core
Manage the Upstream 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, Upstream NPI and MES
Builds
GMP drug substance for clinical trials and commercial production
Domain
Biotechnology / Bioprocessing
Required skills
Team management, GMP operations, New Product Introduction (NPI), Lean Transformation, Operational Excellence, Cross-functional project management, Technical data analysis, Regulatory compliance, Electronic Batch Record (EBR) management, Cell culture and chromatography knowledge
Preferred skills
Chemical/Industrial Engineering degree, PAS X and Werum software experience, Drug substance processing expertise, Coaching and mentoring, Cross-functional leadership
Technologies
PAS X, Werum
Responsibilities
Directly manage a team of Upstream NPI Specialists and MES Sr. Associates; Proactively assess team capabilities to meet evolving supply needs; Lead upstream area team meetings and drive alignment in business processes; Coordinate with cross-functional partners for new product and technology introductions; Champion Lean Transformation and OE initiatives; Collaborate with Regulatory and Quality partners for compliance; Drive a culture of inspection readiness.
Seniority
Manager, hands-on leadership
