Specialist Manufacturing-New Product Introduction (NPI)
Amgen
Summary
In this vital role you will communicate and interface between the GMP manufacturing teams in the plant and process development scientific groups.
Job description
What you will do
- New Product Introduction lead coordinating with Supply Chain, Planning, Facilities and Engineering, Quality, as well as Manufacturing to introduce new Drug Substance products and/or advanced technologies into the plant.
- Technical expert who leads or participates in projects, ensuring that production documents are accurate and up to date.
- Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.
- Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
- Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings.
- Generate electronic and paper process documents to ensure plant success. Perform electronic batch record editing and troubleshooting to support production, as required.
Basic Qualifications
- Doctorate degree OR
- Master's degree in chemistry, biology or engineering & 2 years of biotechnology operations experience OR
- Bachelor's degree in chemistry, biology or engineering and 4 years of biotechnology operations experience OR
- Associate's degree in chemistry, biology or engineering & 8 years of biotechnology operations experience OR
- High school diploma / GED & 10 years of biotechnology operations experience
Preferred Qualifications
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
- Excellent technical writing skills and experience with electronic documentation systems
- Experience with PAS X, Werum software with capability to create and edit in EBR
- Experience in GMP operations
- Strong technical knowledge of downstream drug substance processing (chromatography, filtration, buffer compounding) and a broad understanding of upstream processing (cell culture, harvest)
- Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
- Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
- Ability to coach, mentor and/or cross train colleagues within core technical areas
- Background in lean manufacturing methodologies and operational excellence
- Experience in cross functional Project Management
Requirements
- Doctorate degree OR
- Master's degree in chemistry, biology or engineering & 2 years of biotechnology operations experience OR
- Bachelor's degree in chemistry, biology or engineering and 4 years of biotechnology operations experience OR
- Associate's degree in chemistry, biology or engineering & 8 years of biotechnology operations experience OR
- High school diploma / GED & 10 years of biotechnology operations experience
Benefits
- Health Insurance
- Dental Coverage
- Vision Coverage
- Life Insurance
- Disability Insurance
- Retirement and Savings Plan
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-Based Long-Term Incentives
- Time-Off Plans
- Flexible Work Models
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.