External Manufacturing Organization (EMO) - Manager/ Sr Manager
About The Position
The Manager of CMO Operations oversees outsourced production, technical transfers, and routine manufacturing activities across multiple contract manufacturing organizations to ensure reliable supply, regulatory compliance, and high-quality performance. You will coordinate between external partners and internal stakeholders across the CMC Lifecycle (Development, Clinical, MSAT, Operations, Regulatory, others) to drive our outsourcing product portfolio. This role will be the Single Point of Contact (SPOC) to our external partners for contract management, coordination, execution, and issues resolution. When needed you will act as the "Person-in-Plant", providing on the floor oversight of CMO facilities to ensure compliance with current Good Manufacturing Practices (cGMP) in collaboration with Quality and Technical teams.
Requirements
- Bachelor’s degree in engineering, life sciences, or related field.
- 10+ years of experience in biomanufacturing or regulated life sciences operations
- 8+ years of experience in GMP environment
- Proven leadership experience managing muti-site CMO organization
- Working knowledge of biomolecules manufacturing (e.g., cell culture, purification, fill-finish)
- Experience scaling operations and expanding manufacturing capacity
- Ability to collaborate within a matrixed organization
- Track record of success partnership roles, influencing up and down the organization, driving cultural transformation and operational excellence
- Mentoring, coaching and teaching ability and orientation
- People development, performance management and change management are necessary skills for success
- Financial metrics and acumen pertaining to site performance
Nice To Haves
- Preference given to advanced degrees (e.g., MS, MBA or PhD in similar fields).
Responsibilities
- Manage day-to-day operations with assigned CMOs, ensuring alignment with production schedules and business objectives
- Build and maintain strong, collaborative relationships with external partners
- Lead regular business reviews and performance discussions
- Ensure timely production, release, and delivery of drug substances and/or drug products
- Monitor manufacturing performance metrics (e.g., yield, deviations, on-time delivery)
- Partner with Supply Chain to support demand planning and inventory management
- Ensure all manufacturing activities comply with GMP and global regulatory requirements
- Support investigations, deviations, CAPAs, and change controls in collaboration with Quality teams
- Participate in audits and regulatory inspections as needed
- Provide oversight for tech transfer, process validation, and lifecycle management
- Collaborate with MSAT teams on process improvements
- Troubleshoot manufacturing issues and drive resolution with CMOs
- Lead cross-functional initiatives related to external manufacturing
- Track milestones, risks, and deliverables for CMO-related projects
- Ensure effective communication across internal teams (Manufacturing, Quality, Regulatory, Supply Chain, MSAT, R&D)
- Identify opportunities to optimize cost, efficiency, and quality
- Implement best practices and operational improvements across CMO network
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What This Job Offers
Job Type
Full-time
Career Level
Manager
