CMC Operations Lead—External Manufacturing & CDMO Strategy

Biopharma Careers

Cambridge (MA)

On-site

USD 138,000 - 185,000

Full time

8 days ago

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Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

15 days paid vacation + year-end time

12 company holidays + 3 personal days

80 hours of sick time per year

Parental Leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement up to $10,000

Employee Resource Groups

Job summary

Biogen in Cambridge, MA is seeking a Senior Manager, CMC Operations to lead external development and manufacturing activities from IND-enabling studies through Phase 2 across programs. You will coordinate CDMO partnerships, align with R&D, Quality, Supply Chain and Finance, and build scalable governance and processes to deliver quality, cost, and timelines.

The role emphasizes strategic execution and cross-functional leadership, with a base salary range and comprehensive benefits.

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 and manufacturing.
Experience in early-phase CMC development and manufacturing operations.
Expertise in external partnership and CDMO management.
Strong cross-functional leadership and stakeholder management.
Ability to design and optimize business processes and operational frameworks.

Responsibilities

Develop and drive integrated external development and manufacturing plans across programs and CDMOs.
Lead operational engagement with CDMOs in early-phase development programs.
Ensure delivery to quality, cost, and timeline expectations.
Track and manage spend with CDMOs.
Establish scalable governance and risk tracking frameworks.
Coordinate cross-functional execution and interdependencies.