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Associate Manufacturing- Bulk Drug Substance - Services- DayShift

BioSpace

Amgen Mission of Serving Patients Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – oncology, inflammation, general medicine, and rare disease – we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Associate Manufacturing – Bulk Drug Substance – Services – Day Shift In this dynamic role, you will be an associate in the manufacturing organization at Amgen North Carolina (ANC). The essential position supports our critical 24/7 manufacturing operations and works a 12‑hour 2‑2‑3 schedule from 5:45 am to 6:15 pm. Associates will be completing floor operations in our manufacturing services area and will be responsible for the manufacturing of cGMP drug substances. What You Will Do You will support all floor operations in accordance with cGMP practices, ensuring regular attendance during 12‑hour shifts, including inclement weather, certain holidays, and requested overtime to meet business needs. Compliance Complete work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance. Assure proper gowning and aseptic techniques are always followed. Process/Equipment/Facilities Perform hands‑on operations including set‑up, cleaning, sanitization, and monitoring of equipment in assigned area. Run and monitor critical process tasks per assigned procedures. Prepare and transfer buffers and media. Weigh and dispense materials used in the preparation of buffers and media. Perform in‑process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records). Complete washroom activities: cleaning equipment, from small to large scale, used in production activities. Identify and escalate issues and concerns related to daily routine functions; engage with team on potential solutions. Document assigned functions (equipment logs, EBRs). Collaborate as part of a cross‑functional team (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities. Maintain an organized, clean, and workable space. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. We seek team players with the following qualifications. Basic Qualifications High School/GED + 2 years manufacturing and/or other regulated environment experience. Associate’s Degree + 6 months manufacturing and/or other regulated environment experience. Bachelor’s Degree. Preferred Qualifications Completion of NCBioWork Certificate Program. Experience in a regulated industry such as biotechnology or pharmaceutical. Basic understanding and process experience in a cGMP manufacturing facility. Excellent verbal and written communication. Proficient Microsoft Office skills and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems. Demonstrated desire and drive to learn and grow understanding of operations and processes. What You Can Expect Of Us The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including relevant skills, experience, and qualifications. Benefits 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 and bi‑annual company‑wide shutdowns. Flexible work models, including remote work arrangements where possible. No relocation assistance will be provided for these positions. Equal Opportunity Employer Amgen is committed to equal employment opportunity and welcoming diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, veteran status, or any other protected characteristic. #J-18808-Ljbffr BioSpace

Vacancy posted 2 days ago
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