Senior Manager, CMC Operations
Biogen
August 29, 2026
Remote friendly (Cambridge, MA)
United States
Operations
About This Role
As the Senior Manager, CMC Operations, you will oversee external development and manufacturing activities from IND-enabling studies through Phase 2 across multiple programs. You will serve as the CMC Pharma interface to CDMOs, ensuring consistent execution and partner performance. With the General Manager, you will operationalize the CMC Pharma function by establishing business processes, governance frameworks, and ways of working to support a scalable external development model, partnering across R&D, Quality, Supply Chain, and Finance to enable seamless transition into GMP operations.
What You’ll Do
- Develop, maintain, and drive integrated external development and manufacturing project plans across multiple programs and CDMOs.
- Lead operational engagement with CDMOs.
- Ensure delivery to quality, cost, and timeline expectations.
- Support contracting and partner performance management; track and manage spend with CDMOs.
- Establish continuous improvement of business processes/execution models; develop scalable operational frameworks, governance, and risk tracking.
- Standardize workflows; integrate technical, manufacturing, quality, supply chain, procurement, and CDMO activities into coordinated execution plans.
- Drive cross-functional team alignment to meet milestones; identify/manage cross-program dependencies, resource constraints, and schedule conflicts.
- Provide input into outsourcing strategy and CDMO engagement models.
- Track/communicate risks and performance metrics; support governance processes.
Who You Are / Required Skills
- Bachelor’s in Chemical Engineering, Chemistry, or closely allied discipline.
- 8+ years (BS) or 5+ years (MS/PhD) in biotechnology or pharmaceutical CMC development and manufacturing.
- Strong early-phase CMC development/manufacturing operations.
- Expertise in external partnership and CDMO management; ability to design/optimize operational frameworks.
- Strong cross-functional leadership, stakeholder management, organizational, and project management skills.
- Ability to manage complex execution challenges; strategic thinking.
Preferred Skills
- Experience with governance frameworks and risk tracking.
- Familiarity with integrating technical/manufacturing/supply chain activities.
- Ability to identify/manage cross-program dependencies and resource constraints.
Benefits (if applicable)
- Base compensation range: $138,000.00–$185,000.00
- Medical, Dental, Vision, Life; Fitness/Wellness reimbursement; Short/Long-term disability; 15+ days paid vacation; paid holidays; sick time; Paid Maternity/Parental Leave; 401(k) match; Employee stock purchase plan; Tuition reimbursement up to $10,000/year; Employee Resource Groups.
As the Senior Manager, CMC Operations, you will oversee external development and manufacturing activities from IND-enabling studies through Phase 2 across multiple programs. You will serve as the CMC Pharma interface to CDMOs, ensuring consistent execution and partner performance. With the General Manager, you will operationalize the CMC Pharma function by establishing business processes, governance frameworks, and ways of working to support a scalable external development model, partnering across R&D, Quality, Supply Chain, and Finance to enable seamless transition into GMP operations.
What You’ll Do
- Develop, maintain, and drive integrated external development and manufacturing project plans across multiple programs and CDMOs.
- Lead operational engagement with CDMOs.
- Ensure delivery to quality, cost, and timeline expectations.
- Support contracting and partner performance management; track and manage spend with CDMOs.
- Establish continuous improvement of business processes/execution models; develop scalable operational frameworks, governance, and risk tracking.
- Standardize workflows; integrate technical, manufacturing, quality, supply chain, procurement, and CDMO activities into coordinated execution plans.
- Drive cross-functional team alignment to meet milestones; identify/manage cross-program dependencies, resource constraints, and schedule conflicts.
- Provide input into outsourcing strategy and CDMO engagement models.
- Track/communicate risks and performance metrics; support governance processes.
Who You Are / Required Skills
- Bachelor’s in Chemical Engineering, Chemistry, or closely allied discipline.
- 8+ years (BS) or 5+ years (MS/PhD) in biotechnology or pharmaceutical CMC development and manufacturing.
- Strong early-phase CMC development/manufacturing operations.
- Expertise in external partnership and CDMO management; ability to design/optimize operational frameworks.
- Strong cross-functional leadership, stakeholder management, organizational, and project management skills.
- Ability to manage complex execution challenges; strategic thinking.
Preferred Skills
- Experience with governance frameworks and risk tracking.
- Familiarity with integrating technical/manufacturing/supply chain activities.
- Ability to identify/manage cross-program dependencies and resource constraints.
Benefits (if applicable)
- Base compensation range: $138,000.00–$185,000.00
- Medical, Dental, Vision, Life; Fitness/Wellness reimbursement; Short/Long-term disability; 15+ days paid vacation; paid holidays; sick time; Paid Maternity/Parental Leave; 401(k) match; Employee stock purchase plan; Tuition reimbursement up to $10,000/year; Employee Resource Groups.