Senior Manager, CMC Operations

Biogen•Cambridge, MA

12d•$138,000 - $185,000•Hybrid

About The Position

As the Senior Manager, CMC Operations, you will be an essential operational leader within our Early Phase Development & Manufacturing team. Your primary responsibility will be overseeing external development and manufacturing activities from IND-enabling studies through Phase 2 across multiple programs. This position ensures that development and manufacturing activities are delivered in alignment with quality, cost, and timeline expectations. You will serve as the CMC Pharma interface to CDMOs, ensuring consistent execution and partner performance. In collaboration with the General Manager, you will operationalize the CMC Pharma function by establishing and optimizing business processes, governance frameworks, and ways of working to support a scalable external development model. Your role will involve partnering across functions such as R&D, Quality, Supply Chain, and Finance to ensure alignment and seamless transition into GMP operations. As the primary operational integrator, you will develop and manage integrated development and manufacturing plans, coordinate activities across CDMOs and internal functions, and proactively manage interdependencies, risks, and critical path timelines.

Requirements

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 CDMOs.
Exceptional organizational and project management skills.

Nice To Haves

Experience with governance frameworks and risk tracking.
Familiarity with integrating technical, manufacturing, and supply chain activities.
Ability to identify and manage cross-program dependencies and resource constraints.

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.

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation