Manufacturing Programs Senior Manager: Cleaning Validation

Amgen•Holly Springs, NC

1d•Onsite

About The Position

Amgen is seeking a Manufacturing Programs Senior Manager for Cleaning Validation to join their Manufacturing Support team at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This role will lead cleaning validation teams for both the existing and new ANC Biologics Drug Substance Manufacturing plants, supporting manufacturing plants in different lifecycle phases. It is a highly visible role with key responsibilities in ensuring compliance of the cleaning validation program to regulatory expectations, driving continual 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 drive improved productivity. This position is part of Amgen's newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility, which combines disposable technologies with traditional stainless-steel equipment and integrates sustainability innovations.

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.