Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days
Amgen
Summary
Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations.
Job description
What you will do
In this dynamic role, you will be an Associate in the Manufacturing organization at Amgen North Carolina (ANC), supporting the ANC2 facility expansion and startup program. This essential role will be part of the Services team responsible for enabling manufacturing operations through weigh and dispense of raw materials, material receiving and handling, media, buffer, and solution preparation, and component preparation activities, including parts washing and autoclave operations. You will also partner across functions to support successful operational readiness, technology transfer, facility startup, and the ramp-up of manufacturing operations within the new facility.
This role may require work outside standard business hours, including non-standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. During this phase of startup, you will be expected to work a Monday through Friday schedule from 8:00 a.m. to 5:00 p.m. As the business transitions from C&Q to manufacturing operations, this essential position will move to a 12-hour, 2-2-3 schedule from 5:45 a.m. to 6:15 p.m., supporting critical 24/7 manufacturing operations.
Responsibilities
- Completes 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
- Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment in assigned area
- Run and monitor critical process tasks per assigned procedures
- Buffer and Media preparation and transfer
- Weigh and dispense of materials to be used in the preparation of Buffers and Medias
- 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 escalate 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 (i.e., QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities
- Maintain an organized, clean, and workable space
Requirements
- High School/GED + 2 years manufacturing and/or other regulated environment experience
- Or Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
- Or Bachelor’s Degree
- 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
- An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Retirement and savings plan
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus
- Stock-based long-term incentives
- Paid time off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.