Manufacturing Programs Senior Manager: Cleaning Validation
About The Position
Amgen is seeking a Manufacturing Programs Senior Manager for Cleaning Validation to join their Manufacturing Support team. This role will 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 is a highly visible role across the site, responsible for ensuring the compliance of the cleaning validation program with regulatory expectations, driving continuous improvement, and maintaining alignment with network lessons learned and best practices. The role also offers opportunities to propose, participate in, and lead team improvement initiatives to enhance productivity.
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
- A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Managerial experience may run concurrently with the required technical experience.
Nice To Haves
- 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.
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.
Benefits
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program.
- Stock-based long-term incentives.
- Award-winning time-off plans and bi-annual company-wide shutdowns.
- Flexible work models, including remote work arrangements, where possible.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
