Associate Manufacturing
Amgen
Summary
The Associate of Manufacturing will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant, supporting development, clinical, and launch activities. Under general supervision, this role performs manufacturing operations within Building 23 in accordance with Standard Operating Procedures (SOPs).
Job description
This position is responsible for hands-on manufacturing operations, including setup, cleaning, sanitization, media and buffer preparation, and analytical testing.
Key Responsibilities
- Perform and monitor critical manufacturing processes
- Execute routine validation protocols
- Comply with GMP requirements and all safety and compliance expectations
- Draft and revise routine documents such as MPs, SOPs, and technical reports
- Initiate and own quality records, including CAPA and CAPA-EV
- Identify and recommend improvements to routine functions and implement approved changes
- Perform basic troubleshooting and accurately recognize and report problems
- Direct operators on critical processes
- Assist in the review of documentation for assigned functions, including routine area audits and batch records
- Perform activities that may include rigorous and repetitive work
- Work around high-pressure systems and occasionally around heavy equipment
- Train staff on hands-on tasks, as needed
- Serve as a safety representative, as needed
- Participate on cross-functional teams and represent Manufacturing, as needed
- Apply technical, scientific, operational, and compliance knowledge to support implementation of new technologies into the plant
- Demonstrate strategic problem-solving skills and champion continuous improvement
Work Environment
- Must be available to work onsite
- Must be able to work in a clean room environment wearing steel-toe shoes, full clean room gowning, hairnet, and gloves while following GMP documentation with strict adherence to safety and compliance
- Must be available to work various shifts, including day, swing, graves, weekends, holidays, 5x8-hour shifts, 4x10-hour shifts, and 3x12- or 4x12-hour shifts, as dictated by the production schedule
Requirements
- High school diploma / GED and 2 years of manufacturing or operations work experience, or
- Associate degree and 6 months of manufacturing or operations work experience, or
- Bachelor's degree
- Bachelor's degree in science or engineering
- Knowledge of large-scale biotechnology operations such as purification, cell culture, and aseptic processing
- Knowledge of single-use systems
- CFR and regulatory knowledge
- Mechanical aptitude
- Basic statistical and mathematical skills
- Ability to interpret and apply GMP knowledge
- Understanding of analytical methods used in a manufacturing environment
- Demonstrated technical writing capability
- Project management and presentation skills
- Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles
- Basic troubleshooting skills for production equipment
- Experience with Delta V
- Experience with lab equipment and testing
Benefits
- Retirement and savings plan
- Group medical coverage
- Dental coverage
- Vision coverage
- 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.