Lead Downstream NPI & MES Manager, GMP Drug Substance

BioSpace; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Amgen in Thousand Oaks is seeking a Downstream Manager for the New Product Introduction (NPI) and Manufacturing Execution Systems (MES) team. You will lead the NPI/MES group within the GMP DSS plant, collaborating with Process Development, Quality, Supply Chain and Engineering to introduce new products and implement electronic batch records.

The role requires proven people leadership, experience in GMP operations and NPI, and strong cross‑functional collaboration.

Qualifications

• Leadership experience managing teams, projects or programs.
• Experience in GMP operations and New Product Introduction (NPI).
• Strong cross-functional collaboration and communication skills.

Responsibilities

• Directly manage a team of Downstream NPI Specialists and MES Sr. Associates responsible for introduction of new products and/or advanced technologies into the plant, as well as Electronic Batch Record (EBR) development and management.
• Proactively assess team capabilities to meet evolving drug substance needs and cross-functional alignment.
• Lead downstream area team meetings and drive alignment in business processes across the team.
• Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality, MES network, as well as Manufacturing for the introduction of new products and EBRs.
• Champions Lean Transformation and OE initiatives and tracks progress on a plant level.
• Collaborate with Regulatory and Quality to ensure compliance of team change control records/documents and respond to regulatory questions.
• Drive a culture of inspection readiness by ensuring NPI and MES playbooks are up to date and supporting staff with audit strategy.

Skills

Team leadership

Project management

Lean manufacturing

GMP operations

Education

Bachelor's degree in Biotechnology

Master's degree in Biotech/Engineering

Tools

PAS X

Werum

Job description

Amgen in Thousand Oaks is seeking a Downstream Manager for the New Product Introduction (NPI) and Manufacturing Execution Systems (MES) team. You will lead the NPI/MES group within the GMP DSS plant, collaborating with Process Development, Quality, Supply Chain and Engineering to introduce new products and implement electronic batch records.

The role requires proven people leadership, experience in GMP operations and NPI, and strong cross‑functional collaboration.