Cleaning Validation Programs Lead – Biologics Ops & Lean

Amgen Inc.; Holly Springs (NC); On-site; USD 136,000 - 184,000; Full time

Benefits offered by this job

Remote work arrangements

Stock-based incentives

Job summary

Amgen Inc. in North Carolina is seeking a Manufacturing Programs Senior Manager: Cleaning Validation to lead cross-functional teams across two biologics DS plants.

You will drive cleaning validation delivery, ensure compliance with regulatory expectations, and advance continuous improvement within the ANC network. Ideal candidates bring biotech manufacturing validation experience, strong project management, and a track record of leading teams through complex regulatory programs.

Qualifications

• Doctorate in chemistry, biology or engineering with biotechnology ops experience or
• Master’s in chemistry, biology or engineering with biotechnology ops experience or
• Bachelor’s with biotechnology ops experience or
• Associate’s with biotechnology ops experience or
• HS diploma with biotechnology ops experience

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.
• Establishes Cleaning Validation Program standard work and best practices; ensure inspection readiness.
• Champions Lean Transformation and OE initiatives; track plant-level progress.

Skills

Leadership

Project management

Cross-functional collaboration

Regulatory knowledge

Quality improvement

Education

PhD in Chemistry/Biology/Engineering

MS in Chemistry/Biology/Engineering

BS in Chemistry/Biology/Engineering

AS/AA in related field

HS diploma

Tools

GMP familiarity

Job description

Amgen Inc. in North Carolina is seeking a Manufacturing Programs Senior Manager: Cleaning Validation to lead cross-functional teams across two biologics DS plants.

You will drive cleaning validation delivery, ensure compliance with regulatory expectations, and advance continuous improvement within the ANC network. Ideal candidates bring biotech manufacturing validation experience, strong project management, and a track record of leading teams through complex regulatory programs.