Associate Manufacturing - Days
Amgen
Summary
In this vital role you will join a team of impactful manufacturing associates that leverage adaptability, agility, teamwork, and curiosity. The Manufacturing Associate I at Amgen supports the production process by operating equipment, maintaining production records, and adhering to safety and quality standards. They contribute to the overall efficiency of the manufacturing process.
Job description
The on-boarding phase for this role will last 2-6 weeks, during which time successful incumbents will be on an administrative schedule (Monday through Friday, approximately 8am to 5pm). Following the on-boarding phase, the successful incumbent will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7am-7pm with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay.
Responsibilities
- Under general supervision, perform operations in the manufacturing area according to Standard Operating Procedures (SOPs)
- Perform and monitor critical processes, complete routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports
- Perform basic troubleshooting and assist in the review of documentation for assigned functions
- May participate on cross-functional teams and represent the manufacturing teams
- May own deviations/CAPAs
- May identify, recommend, and implement improvements related to routine functions
Basic Qualifications
- High school/GED + 2 years of manufacturing or operations work experience OR
- Associate's + 6 months of manufacturing or operations work experience OR
- Bachelor's Degree in a related field
Preferred Qualifications
- Bachelor's degree in Science or Engineering
- Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
- Knowledge of Single-use Systems
- CFR and Regulatory knowledge
- Mechanical ability/expertise
- Basic statistical mathematical skills
- Ability to interpret and apply GMP knowledge
- Understanding of analytical methods for manufacturing area
- Demonstrated technical writing capability
- Able to demonstrate project management skills and presentation skills
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Basic troubleshooting skills on production equipment
- Experience with Delta V
- Experience with lab equipment/testing
Requirements
- High school/GED + 2 years of manufacturing or operations work experience OR Associate's + 6 months of manufacturing or operations work experience OR Bachelor's Degree in a related field
- Bachelor's degree in Science or Engineering (preferred)
- Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing (preferred)
- Knowledge of Single-use Systems (preferred)
- CFR and Regulatory knowledge (preferred)
- Mechanical ability/expertise (preferred)
- Basic statistical mathematical skills (preferred)
- Ability to interpret and apply GMP knowledge (preferred)
- Understanding of analytical methods for manufacturing area (preferred)
- Demonstrated technical writing capability (preferred)
- Project management and presentation skills (preferred)
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles (preferred)
- Basic troubleshooting skills on production equipment (preferred)
- Experience with Delta V (preferred)
- Experience with lab equipment/testing (preferred)
Benefits
- Health Insurance
- Dental Coverage
- Vision Coverage
- Life Insurance
- Disability Insurance
- Retirement & Savings Plan
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-Based Long-Term Incentives
- Time-Off Plans
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.