External Site Lead, Global External Manufacturing

Biogen, Inc.; Cambridge (MA); On-site; USD 142,000 - 190,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Paid vacation & holidays

Job summary

Biogen seeks an External Site Lead to oversee CDMO partnerships, drive manufacturing execution, and ensure robust process controls at external sites. You will manage change controls, technology transfers, and CPV activities while coordinating cross-functional teams across geographies.

You bring 7+ years in device assembly/packaging, CDMO governance, and strong project-management skills to optimize quality, cost, and delivery of biologics manufacturing.

Qualifications

• Bachelor’s degree in related field, preferably in Engineering discipline, and a 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, with the ability to drive impactful decisions.

Responsibilities

• 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 effectively.
• 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.

Skills

Device assembly

Label & packaging

CDMO management

Contracting

Relationship management

Project management

Communication

Analytical

Written skills

Education

Bachelor's degree in Engineering

Job description

About This Role

As an External Site Lead, within our Global External Manufacturing Team, you will be pivotal in overseeing our partnerships with Contract Development and Manufacturing Organizations (CDMOs). The site lead will oversee all activities to ensure seamless manufacturing operations. Your technical expertise in assembly and packaging pharmaceutical and biologics will be crucial as you lead the process control strategy and execution at external manufacturing sites. You'll drive matrix teams to provide operational oversight, manage change controls, analyze scientific datasets, and ensure compliance with regulations. Your role is essential for aligning manufacturing objectives, enhancing efficiency, and fostering continuous improvements that bring value to the business. Collaborating across all levels and functions, you will ensure the delivery of high-quality manufacturing operations, fitting into the broader organizational structure.

What You’ll Do

• 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 effectively.
• 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.

Who You Are

• You are someone with a strong technical understanding of assembly, label and packaging with business acumen to drive the business.
• Your ability to make impactful decisions and act with urgency sets you apart.
• You thrive in cross-functional and multicultural environments, expertly managing conflict and providing clear direction.
• You possess good communication and project management skills, enabling you to lead effectively with internal and external teams.
• Your expertise in control strategies, regulatory compliance and CDMO management makes you a valuable asset to our team.

Required Skills

• Bachelor’s degree in related field, preferably in Engineering discipline, and a 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, with the ability to drive impactful decisions.

Job Level: Management

Additional Information

The base compensation range for this role is: $142,000.00-$190,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

• 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

Biogen is an E-Verify Employer in the United States.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.