Manager, External Manufacturing and Supply

Role Overview

As a Manager, External Manufacturing and Supply Operations, you will be responsible for the end-to-end technical and operational oversight of external manufacturing and supply activities across a network of Contract Manufacturing Organizations (CMOs). This role requires a strong technical foundation, the ability to manage multiple concurrent priorities, and to operate effectively in a fast-paced, ambiguous environment.

What You Will Do

You will provide hands-on technical oversight of manufacturing operations at CMOs, ensure adherence to validated processes, regulatory expectations, and internal standards, and drive investigation and resolution of deviations, OOS/OOT events, and product complaints.

Why It Might Be a Fit

This role is a great fit for someone with strong technical knowledge across Drug Product, API, and Packaging operations, and experience working with external CMOs, providing technical oversight and driving performance in outsourced manufacturing environments.

Requirements

• BS/BA Degree in Life Sciences, Engineering, or related discipline
• 10+ years' experience across pharmaceutical manufacturing, technical operations, or external supply in a regulated environment
• Strong cGMP manufacturing experience within a pharmaceutical plant environment
• Demonstrated expertise in batch record review and approval
• Proven experience working with external CMOs
• Strong technical knowledge across Drug Product, API, and Packaging operations
• Hands-on experience in deviation management, investigations (OOS/OOT), and CAPA implementation
• Solid understanding of process validation, lifecycle management, and continued process verification
• Experience supporting or leading technology transfers and process scale-up activities
• Strong working knowledge of global regulatory requirements (FDA, EMA, ICH, EU GMP)
• Experience with ERP/MRP systems and manufacturing data structures (BOMs, master data)
• Proven ability to apply risk management principles and make sound technical decisions under pressure

Benefits

• Competitive pay range
• Opportunity to work with a passionate team
• Robust scientific thinking and critical thinking
• Integrity and ethics
• Opportunity to make a difference in the lives of patients