Senior Cleaning Validation Programs Leader

amgen; Holly Springs (NC); Hybride; USD 136 000 - 184 000; Plein temps

Avantages offerts par ce poste

Total Rewards Plan

Stock-based incentives

Flexible work model

Résumé du poste

Amgen in North Carolina is seeking a Manufacturing Programs Senior Manager to lead cleaning validation for both existing and new biologics DS plants. You will manage cross-functional teams, ensure regulatory compliance, drive improvements, and align with network lessons learned to boost productivity.

The role requires advanced degrees and substantial biotech operations leadership, strong project management, and excellent written and spoken communication.

Qualifications

• Biologics DS manufacturing background with cross-functional PM and communication skills.
• Experience leading teams, projects, or programs in GMP manufacturing.
• Strong technical knowledge of drug substance processing and bioprocessing.

Responsabilités

• 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; assist CAPA development.
• Establishes Cleaning Validation Program standard work and best practices; align with network.
• Lead Lean Transformation and OE initiatives to improve plant productivity.

Connaissances

Biologics ops experience

People leadership

Cross-functional collab

Regulatory familiarity

Formation

Doctorate in chemistry/biology/engineering

Master’s in chemistry/biology/engineering

Bachelor’s in biotech/engineering

Associate’s + experience

High school + 12y biotech ops

Description du poste

Amgen in North Carolina is seeking a Manufacturing Programs Senior Manager to lead cleaning validation for both existing and new biologics DS plants. You will manage cross-functional teams, ensure regulatory compliance, drive improvements, and align with network lessons learned to boost productivity.

The role requires advanced degrees and substantial biotech operations leadership, strong project management, and excellent written and spoken communication.