CMC Operations Lead – External Development & Manufacturing

Biogen; Cambridge (MA); On-site; USD 138,000 - 185,000; Full time

Benefits offered by this job

401(k) matching

Employee stock purchase plan

Tuition reimbursement

Paid time off

Job summary

Biogen is seeking a Senior Manager, CMC Operations to lead external development and manufacturing activities from IND through Phase 2. You will manage CDMO partnerships, coordinate with R&D, Quality, Supply Chain and Finance, and drive scalable external development models.

Strong project management and stakeholder skills are essential. You will develop integrated plans, monitor spend, and ensure adherence to quality, cost, and timeline expectations while optimizing governance frameworks and risk

Qualifications

• Bachelor’s degree in Chemical Engineering, Chemistry, or closely allied discipline.
• 8+ years (BS) or 5+ years (MS/PhD) in biotech/pharma CMC development/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 CDMOs.
• Exceptional organizational and project management skills.

Responsibilities

• Develop and maintain integrated external development and manufacturing plans across programs and CDMOs.
• Lead operational engagement with CDMOs for early-phase programs.
• Ensure delivery to quality, cost, and timeline expectations.
• Support contracting and partner performance management.
• Track and manage spend with CDMOs.
• Drive continuous improvement of processes and execution models.
• Develop scalable governance and risk tracking frameworks.
• Integrate activities across functions into coordinated plans.
• Drive cross-functional team alignment to milestones.
• Identify cross-program dependencies and resource constraints.
• 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

Early-phase CMC operations

Cross-functional leadership

Process design & optimization

Program management

Spend management with CDMOs

Strategic thinking

Quality, cost, on-time delivery

Organizational skills

Bachelor’s in Chemical Eng/ Chemistry

Education

Bachelor’s degree in Chemical Engineering, Chemistry, or closely allied discipline

Job description

Biogen is seeking a Senior Manager, CMC Operations to lead external development and manufacturing activities from IND through Phase 2. You will manage CDMO partnerships, coordinate with R&D, Quality, Supply Chain and Finance, and drive scalable external development models.

Strong project management and stakeholder skills are essential. You will develop integrated plans, monitor spend, and ensure adherence to quality, cost, and timeline expectations while optimizing governance frameworks and risk