Manager - New Product Introduction (NPI) and Manufacturing Execution System (MES)

Amgen seeks a Manager for New Product Introduction and Manufacturing Execution Systems at its Thousand Oaks facility. This leader will oversee a team introducing new products and technologies into GMP drug substance manufacturing, manage electronic batch record development, and coordinate across process development, supply chain, quality, and engineering. The role emphasizes team development, continuous improvement, regulatory compliance, and cross-functional collaboration.

Responsibilities

• Manage downstream NPI Specialists and MES Associates; conduct hiring, training, evaluations, and development
• Assess team capabilities and resources to meet evolving drug substance supply needs
• Lead team meetings and drive cross-functional alignment on business processes
• Coordinate new product introductions, electronic batch records, and advanced technologies with multiple departments
• Champion lean transformation and operational excellence initiatives; track plant-level progress

Requirements

• Doctorate degree, or Master's with 3+ years biotech operations experience, or Bachelor's with 5+ years, or Associate's with 10+ years
• Direct people management experience and/or leadership of teams, projects, or programs
• Experience with GMP operations and new product introduction processes
• Technical knowledge of drug substance processing including cell culture, chromatography, and filtration
• Ability to organize, analyze, and communicate complex technical data effectively
• Preferred: Chemical, Industrial Engineering, Biology, or Biochemistry degree
• Preferred: Experience with PAS X or Werum software systems