Associate Manufacturing - Bulk Drug Substance - Services - Day Shift

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, works a 12-hour 2‑2‑3 schedule from 5:45 a.m. to 6:15 p.m. Associates will be completing operations on the floor in our manufacturing services area and will be responsible for the manufacturing of cGMP drug substances. With general direction, the Associate will support all floor operations in accordance with cGMP practices. As Amgen relies upon regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12‑hour shifts, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations. Responsibilities Complete work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance. Assure proper gowning and aseptic techniques are always followed. 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. Buffer and media preparation and transfer. Weigh and dispense materials for buffer and media preparation. Perform in‑process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]). Complete washroom activities: cleaning equipment, small to large scale, used in production activities. Identify and elevate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions. Perform documentation for assigned functions (i.e., equipment logs, EBRs). Collaborate as part of a cross‑functional team (QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities. Maintain an organized, clean, and workable space. Basic Qualifications High School or 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 NC BioWork 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 other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems. Ability to demonstrate desire and drive to learn and grow understanding of operations and processes. Benefits 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 but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals, work/life balance, and career development opportunities including: 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. #J-18808-Ljbffr Amgen SA