Senior CMC Operations Lead — External Development & CDMOs

Biogen, Inc.; Cambridge (MA); Hybrid; USD 138,000 - 185,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins

Fitness & Wellness reimbursement

Short- and Long-Term Disability

Vacation 15 days + year-end shutdown

Up to 12 holidays + 3 personal days

Sick time 80 hours/year

Maternity and Parental Leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen, Inc. seeks a Senior Manager, CMC Operations to oversee external development and manufacturing from IND-enabling studies through Phase 2 across multiple programs.

You will serve as the CMC Pharma interface to CDMOs and partner with R&D, Quality, Supply Chain, and Finance to ensure alignment with GMP operations. You will develop and manage integrated development and manufacturing plans, drive governance frameworks, and manage interdependencies and risks while ensuring cost, quality, and

Qualifications

• Bachelor’s degree in Chemical Engineering, Chemistry, or closely allied discipline.
• Minimum 8+ years (BS) or 5+ years (MS/PhD) of relevant experience in biotechnology or pharmaceutical CMC development and manufacturing.
• Strong experience in early-phase CMC development and manufacturing operations.
• Expertise in external partnership and CDMO management.
• Ability to design and optimize business processes and operational frameworks.
• Strong cross-functional leadership and stakeholder management.
• Ability to manage complex execution challenges and drive resolution.
• Strategic thinking with execution focus.
• External spend management with CDMO.

Responsibilities

• Develop, maintain, and drive integrated external development and manufacturing project plans across multiple programs and CDMOs.
• Lead operational engagement with CDMOs across early-phase development and manufacturing programs.
• Ensure delivery to quality, cost, and timeline expectations.
• Support contracting and partner performance management.
• Track and manage spend with CDMOs.
• Establish and drive continuous improvement of business processes and execution models.
• Develop scalable operational frameworks, governance, and risk tracking.
• Standardize workflows to improve consistency and efficiency.
• Integrate technical, manufacturing, quality, supply chain, procurement, and CDMO activities into coordinated execution plans.
• Drive cross-functional project team alignment and accountability to meet program milestones.
• Identify and manage cross-program dependencies, resource constraints, and schedule conflicts.
• Provide input into outsourcing strategy and CDMO engagement models.
• Track and communicate risks and performance metrics.
• Support governance processes with operational insights.

Skills

External partnership management

CDMO management

Cross-functional leadership

Strategic thinking

Project management

Execution focus

Risk tracking

Stakeholder management

Education

Bachelor’s degree in Chemical Engineering or related

MS/PhD in Chemical Engineering or related (preferred)

Job description

Biogen, Inc. seeks a Senior Manager, CMC Operations to oversee external development and manufacturing from IND-enabling studies through Phase 2 across multiple programs.

You will serve as the CMC Pharma interface to CDMOs and partner with R&D, Quality, Supply Chain, and Finance to ensure alignment with GMP operations. You will develop and manage integrated development and manufacturing plans, drive governance frameworks, and manage interdependencies and risks while ensuring cost, quality, and