Manufacturing Programs Lead, Drug Substance

Amgen SA; Thousand Oaks (CA); On-site; USD 121,000 - 163,000; Full time

Benefits offered by this job

Comprehensive benefits

Bonus program

Stock-based incentives

Generous time-off

Flexible work models

Job summary

Amgen in the United States is seeking a Manager Manufacturing to lead a team responsible for drug substance production, process development, and continual improvement. The role drives operational readiness for new technologies and ensures compliant GMP documentation and validation activities.

The ideal candidate will have extensive experience managing people and projects, with a strong background in upstream manufacturing and quality systems.

Qualifications

• Doctorate or equivalent highest degree in a relevant field.
• Master’s/Bachelor’s/Associate/High school with manufacturing/ops experience requirements.

Responsibilities

• Lead a team of manufacturing specialists in upstream manufacturing.
• Demonstrate strategic problem-solving and drive continual improvement.
• Manage projects using formal project management skills.
• Lead readiness of new technologies, equipment, or processes for GMP drugs.
• Assess and advise on process changes affecting operations.
• Develop/manufacture drug substance processes; draft GMP docs (SOPs).
• Write validation protocols/reports for cleaning validation and commissioning.
• Handle Quality Records (CCMS, CAPA, deviations)
• Draft/revise GMP manufacturing documents (SOPs)

Skills

People management

Project management

Leadership

Quality systems

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen in the United States is seeking a Manager Manufacturing to lead a team responsible for drug substance production, process development, and continual improvement. The role drives operational readiness for new technologies and ensures compliant GMP documentation and validation activities.

The ideal candidate will have extensive experience managing people and projects, with a strong background in upstream manufacturing and quality systems.