Manufacturing Programs Senior Manager: Cleaning Validation
Amgen
Summary
Be part of Amgen's newest and most advanced drug substance manufacturing plant. The FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations, featuring best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities and sustainability innovations.
Job description
What you will do
In this vital role you will be part of ANC's Manufacturing Support team, and lead cleaning validation teams for both the existing Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and the new Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This requires managing cleaning validation teams supporting manufacturing plants in different lifecycle phases. It is a highly visible role across the site with the key responsibilities of working cross-functionally to ensure compliance of cleaning validation program to regulatory expectations, driving continual improvement, and maintaining alignment to network lessons learned and best practices. This role will also offer the opportunity to propose, participate, and lead team improvement initiatives to drive improved productivity.
Responsibilities
- Cross-functional collaboration to ensure on-time delivery of cleaning validation deliverables.
- Provides team oversight, ensuring outputs meet quality and regulatory expectations.
- Support Manufacturing in troubleshooting, problem-solving and RCAs. Support CAPA development to prevent error recurrence.
- Establishes Cleaning Validation Program standard work and best practices, ensuring network alignment and incorporation of lessons learned. Accountable for inspection readiness strategy and development of inspection readiness tools, standard work, and staff training.
- Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant, and tracks progress on a plant level.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics DS manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications.
Basic Qualifications
- Doctorate degree in chemistry, biology or engineering & 2 years of biotechnology operations experience or
- Master's degree in chemistry, biology or engineering & 6 years of biotechnology operations experience or
- Bachelor's degree and 8 years of biotechnology operations experience or
- Associate's degree & 10 years of biotechnology operations experience or
- High school diploma / GED & 12 years of biotechnology operations experience
- AND In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
- Excellent cross-functional project management, meeting facilitation, and technical writing skills.
- Experience in GMP manufacturing operations.
- Strong technical knowledge of drug substance processing in Cell Culture or Purification (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing.
- 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.
Requirements
- Doctorate degree in chemistry, biology or engineering & 2 years of biotechnology operations experience or
- Master's degree in chemistry, biology or engineering & 6 years of biotechnology operations experience or
- Bachelor's degree and 8 years of biotechnology operations experience or
- Associate's degree & 10 years of biotechnology operations experience or
- High school diploma / GED & 12 years of biotechnology operations experience
- AND In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
- Excellent cross-functional project management, meeting facilitation, and technical writing skills.
- Experience in GMP manufacturing operations.
- Strong technical knowledge of drug substance processing in Cell Culture or Purification (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing.
- 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.
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-wide shutdowns
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.