External Site Lead, Global External Manufacturing

Job Description

About This Role:
As an External Site Lead on our Global External Manufacturing team, you are a functional leader who brings specialized knowledge and deep expertise in pharmaceutical and biologics manufacturing. Your primary responsibility will be to oversee intermediate complexity CDMO sites, ensuring operational efficiency while minimizing the need for frequent intensive care. Your role is critical in analyzing scientific data sets, managing process controls, and executing manufacturing operations at external supplier sites. With a focus on continuous process verification and improvement, you will enhance the efficiency, quality, and cost-effectiveness of manufacturing operations. Reporting to the General Manager - Americas, your technical and manufacturing leadership will drive the achievement of key goals, adding significant value to our business and integrating seamlessly into our overall business structure.

This is a remote position and candidate can be located anywhere in the United States.

What You’ll Do:

• Lead the technical and manufacturing execution for specific modalities and/or manufacturing nodes at external supplier sites.
• Analyze scientific datasets and provide oversight towards manufacturing operations, including global change controls and deviations.
• Manage technology transfer deliverables, project metrics, and author site-specific Continuous Process Verification (CPV) reports.
• Solve complex manufacturing and compliance issues and develop and implement corrective actions (CAPAs).
• Identify and lead business process optimization opportunities, driving them towards implementation.
• Collaborate with senior leadership and cross-functional teams to ensure alignment and delivery of manufacturing objectives.
• Lead continuous improvement initiatives aimed at enhancing operational efficiency, quality, and cost-effectiveness.
• Manage external relationship management expertise, including CDMO and/or CLO engagement from site selection through contract negotiation and performance reviews.
• Drive and monitor supplier performance, ensuring compliance with Biogen procedures and cGXP regulations.
• Own the vendor team engagement, partnering with the General Manager for governance execution.

Qualifications

Who You Are:

You are a technical subject matter expert who is not only skilled in your discipline but also adept at integrating knowledge across various domains. Your ability to drive innovative projects forward with a collaborative and inclusive approach makes you a valuable asset. You are experienced in leading cross-functional teams and capable of making impactful decisions with a sense of urgency. In your role, you exhibit strong analytical and written skills, combining technical depth with project management discipline. You thrive in both individual and leadership roles, managing conflict constructively and navigating multi-cultural environments with ease. Your expertise in external CDMO management, governance, contracting, and relationship management positions you as a key influencer in achieving process and partnership priorities.

Required Skills:

• Bachelor's degree in a related field with a minimum of 10 years of experience. Equivalent experience equates to a Masters and 8 years of experience or a PhD and 5 years of experience.
• Technical subject matter expertise corresponding to the manufacturing site designation (emphasis on oral solid dose drug products).
• Experience across Operations and Supplier Relationship Management roles.
• Proven track record of successful CDMO relationship management and governance execution.
• Solid technical understanding of process control strategies for specific modalities and/or nodes.
• Strong analytical, written, communication, and project management skills.
• Proficiency in resolving complex technical project management issues in compliance with regulatory expectations and business procedures.
• Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification.

• Expertise in analyzing scientific data sets and managing technical operations.
• Demonstrated ability to drive continuous improvement in a commercial manufacturing environment.

Additional Information

The base compensation range for this role is $146,000-$243,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and