Senior Manager, Cleaning Validation

About the role

Amgen is looking for a Manufacturing Programs Senior Manager for Cleaning Validation to join its Manufacturing Support team. You will lead cleaning validation teams for both the existing Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and the new FleX Batch facility, which combines disposable technologies with stainless steel equipment and includes Industry 4.0 and sustainability features. The role is highly visible across the site, working cross-functionally to keep the cleaning validation program compliant with regulatory expectations, driving continual improvement and sharing lessons learned.

Key responsibilities

• Cross-functional collaboration to deliver cleaning validation deliverables on time
• Team oversight so that outputs meet quality and regulatory expectations
• Support manufacturing in troubleshooting, problem solving and root cause analyses, and support CAPA development to prevent errors from recurring
• Establish cleaning validation program standard work and best practices aligned with the network
• Own the inspection readiness strategy, including inspection readiness tools, standard work and staff training
• Champion Lean Transformation and Operational Excellence initiatives and track progress at plant level

Required profile

• Biologics drug substance manufacturing background with strong cross-functional project management and communication skills
• At least one of: doctorate in chemistry, biology or engineering with 2 years of biotechnology operations experience, master's with 6 years, bachelor's with 8 years, associate's with 10 years, or high school diploma with 12 years of biotechnology operations experience
• Minimum 2 years of direct people management experience or leadership experience leading teams, projects or programs

Required skills

• Preferred: GMP manufacturing operations experience
• Preferred: strong technical knowledge of drug substance processing in cell culture or purification (chromatography, filtration, buffer compounding)
• Preferred: ability to analyze technical data through trend analysis, forecasting and modeling
• Preferred: coaching, mentoring and cross-training colleagues
• Preferred: background in lean manufacturing and operational excellence

What we offer

• Annual base salary range of $136,227.80 to $184,308.20
• Total rewards including health, dental and vision coverage, life and disability insurance, retirement savings plan and flexible spending accounts
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Award-winning time-off plans and flexible work models where possible