Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days
Amgen
Summary
In this dynamic role, you will be a Sr Associate in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45am to 6:15pm. Associates will be executing operations on the floor in our upstream area and will be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances. With general direction, the Senior Associate is responsible for executing on-the-floor operations within manufacturing in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.
Job description
Compliance
- Completes 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
- Initiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.) as well as support or lead evaluations and investigations into quality observations
- Interact with regulatory agencies as needed and guided
- Assure proper gowning and aseptic techniques are always followed
Process/Equipment/Facilities
- Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of assigned area
- Run and monitor critical process tasks per assigned procedures
- Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])
- Complete washroom activities: cleaning equipment, small to large scale, used in production activities
- Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions
- Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs, ESPs)
- Collaborate cross-functionally (i.e., QA/QC, F&E (Facilities & Engineering), PPIC (Production Planning and Inventory Control), Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
- Responsible for recognizing and elevating problems during daily operations
- Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement
- Drive safety in all operations, and assist the manager in escalating concerns as needed
- Maintain an organized, clean, and workable space
Administrative
- Draft and revise documents (SOPs, technical reports, and MPs)
- Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process
Requirements
- High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR Master's Degree
- Completion of NC BioWork Certificate Program
- Experience in biotechnology or pharmaceutical plant start up
- Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
- Basic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration)
- Excellent verbal and written communication (technical) skills
- Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
Benefits
- Competitive total rewards plans
- Professional growth support
- Personal well-being support
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.