Downstream NPI/MES Manager – Manufacturing Excellence

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

Benefits offered by this job

Retirement plan

Stock incentives

Medical, dental and vision coverage

Discretionary bonus

Flexible work models

Job summary

Amgen is seeking a Downstream NPI/MES Manager for the B23 GMP Drug Substance Supply plant in Thousand Oaks. You will lead a team responsible for introducing new products and advanced technologies, developing EBRs, and aligning across PD, Quality, Supply Chain, and Facilities.

You will champion Lean and OE initiatives, ensure regulatory readiness, and drive continuous improvement in manufacturing processes, while coordinating with cross-functional teams and stakeholders.

Qualifications

• PhD or Master’s/Bachelor’s with biotechnology operations experience and leadership.
• Direct people management experience required beyond technical work.
• Experience with GMP operations and New Product Introduction (NPI).

Responsibilities

• Directly manage a team of Downstream NPI Specialists and MES Sr. Associates.
• Coordinate with PD, DSTE, Supply Chain, Planning, Facilities & Engineering, Quality, MES network, and Manufacturing.
• Drive Lean Transformation and OE initiatives across the plant.
• Ensure compliance of change control records/documents with Regulatory and Quality.

Skills

People management

Leadership

GMP operations

NPI

Process development

Project management

Data analysis

Education

Doctorate degree

Master’s degree + 3 years biotech ops

Bachelor’s degree + 5 years biotech ops

Associate’s degree + 10 years biotech ops

Tools

PAS X

Werum software

Job description

Amgen is seeking a Downstream NPI/MES Manager for the B23 GMP Drug Substance Supply plant in Thousand Oaks. You will lead a team responsible for introducing new products and advanced technologies, developing EBRs, and aligning across PD, Quality, Supply Chain, and Facilities.

You will champion Lean and OE initiatives, ensure regulatory readiness, and drive continuous improvement in manufacturing processes, while coordinating with cross-functional teams and stakeholders.