External Site Lead, Global External Manufacturing

Biogen

. Manage and oversee CDMO relationships with a focus on manufacturing execution .

Posted 9/28/2026full-timeCambridge • Massachusetts • United StatesSenior💰 $142,000 - $190,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing CDMO relationships and overseeing manufacturing execution, with a strong focus on compliance with cGMP and FDA/EMA regulations. Proven ability to lead cross-functional teams, drive technology transfers, and implement process optimization strategies.

Highest-signal resume keywords

CDMO ManagementProcess Performance QualificationSupplier Relationship ManagementProject ManagementContinuous Improvement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Device AssemblyLabel and PackagingChange Control ManagementData AnalysisCorrective Action DevelopmentContinuous Process VerificationBusiness Process OptimizationTechnical OversightGovernance ManagementContract Negotiation

Soft Skills

Analytical SkillsCommunication SkillsConflict ManagementDecision-MakingCross-Functional Collaboration

Industry Keywords

CGMPFDA RegulationsEMA RegulationsManufacturing OperationsBusiness Performance Reviews

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Manage and oversee CDMO relationships with a focus on manufacturing execution
Provide technical and operational oversight for assembly, label and pack
Manage global change controls and deviations
Drive, manage, and deliver technology transfers
Analyze scientific datasets to ensure robust process control strategies
Author and review site-specific Continuous Process Verification (CPV) reports
Develop and implement corrective actions and drive business process optimization
Lead continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness
Manage supplier relationship activities from contract negotiation to execution
Conduct business performance reviews and manage partner governance
Act as a primary engagement leader and actively monitor performance
Collaborate across functions and organizational levels to deliver high-quality manufacturing operations

Requirements

What you’ll need

Bachelor’s degree in related field, preferably in Engineering discipline
Minimum of 7 years of experience
Expertise in device assembly and/or label and packaging
Experience in Operations or Supplier Relationship Management
Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification
Expertise in external CDMO management, governance, contracting, and relationship management
Proficiency in project management and communication skills for leading cross-functional teams
Strong analytical and written skills
Technical understanding of assembly, label and packaging
Business acumen
Ability to make impactful decisions and act with urgency
Ability to thrive in cross-functional and multicultural environments
Conflict management and ability to provide clear direction

Benefits

Comp & perks

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
Short term and long-term incentives, including cash bonus and equity incentive opportunities