Manufacturing Specialist

Specialist Manufacturing 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 individual will play an integral role collaborating within a cross‑functional team that includes Manufacturing, Quality Assurance, Process Engineering, Process Development, Analytical Sciences, Quality Sciences, Quality Control, Supply Chain, and Regulatory Affairs. Responsibilities Manage deviation investigations, including assembling investigation teams, leading root cause analysis, development of 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. Clear and concise technical writing. What We Expect Of You The professional we seek is a go‑getter with the following background. Basic Qualifications Doctorate degree. Or Masters degree and 2 years of manufacturing experience. Or Bachelors degree and 4 years of manufacturing experience. Or Associates degree and 8 years of manufacturing experience. Or High school diploma / GED and 10 years of manufacturing experience. Preferred Qualifications 5+ 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 team matrix environment and build relationships with partners. What You Can Expect From Us Amgen offers a competitive Total Rewards Plan including: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A 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 work 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. Please contact us to request accommodation. #J-18808-Ljbffr BioSpace