Senior Associate Manufacturing

Senior Associate Manufacturing What you will do

In this vital role you will investigate deviations in the Amgen Thousand Oaks Manufacturing Clinical Supply Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, Quality Control, and Warehouse Operations.

These investigations are aligned with regulatory requirements and include determination of scope, product impact, root cause, and effective corrective/preventative actions (CAPAs). This role collaborates with a cross‑functional team including Manufacturing, Quality Assurance, Process Engineering, Process Development, Analytical Sciences, Quality Sciences, Quality Control, Supply Chain, and Regulatory Affairs.

• Manage deviation investigations, including assembling investigation teams, leading root cause analysis, developing CAPAs, and compliant documentation of all findings.
• Drive improvements to the investigation process.
• Defend investigations to regulatory inspectors and internal auditors.
• Present complex topics clearly to large and small groups at all levels in the company.
• Build effective relationships across functions.
• Write clear and concise technical documentation.

We seek a go‑getter with the following qualifications.

• Master’s degree; OR
• Bachelor’s degree and 6 months of manufacturing experience; OR
• Associate’s degree and 2 years of manufacturing experience; OR
• High school diploma / GED and 4 years of manufacturing experience.

• 3+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility.
• Degree in Science or Engineering.
• Experience leading complex investigations.
• Demonstrated project management ability.
• Excellent written and verbal communication skills.
• Ability to work in a matrix environment and build relationships with partners.

We offer a competitive Total Rewards Plan and a comprehensive benefits package, including:

• Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models, including remote and hybrid arrangements, where possible.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.