Full-Time External Site Lead

About This Role: As an External Site Lead, you are a functional leader with specialized knowledge in pharmaceutical and biologics manufacturing. You'll oversee intermediate complexity CDMO sites, ensuring operational efficiency and minimizing intensive care needs. Key responsibilities include analyzing scientific data, managing process controls, and executing manufacturing operations at external supplier sites.

What You’ll Do:

• Lead technical and manufacturing execution for specific modalities or manufacturing nodes at external supplier sites.
• Analyze scientific data and oversee manufacturing operations, including change controls and deviations.
• Manage technology transfer deliverables, project metrics, and site-specific Continuous Process Verification (CPV) reports.
• Solve complex manufacturing and compliance issues, developing and implementing corrective actions (CAPAs).
• Identify and lead business process optimization opportunities.
• Collaborate with senior leadership and cross-functional teams to ensure alignment and delivery of manufacturing objectives.
• Lead continuous improvement initiatives.
• Manage external relationship management, including CDMO engagement from site selection to contract negotiation and performance reviews.
• Drive and monitor supplier performance, ensuring compliance with Biogen procedures and cGXP regulations.
• Own vendor team engagement and partner with the General Manager for governance execution.

Who You Are:

• A technical expert capable of integrating knowledge across various domains.
• Experienced in leading cross-functional teams and making impactful decisions with urgency.
• Strong analytical and written communication skills, combining technical depth with project management discipline.
• Thrive in individual and leadership roles, managing conflict constructively and navigating multi-cultural environments.
• Expertise in external CDMO management, governance, contracting, and relationship management.

Required Skills:

• Bachelor's degree in a related field with 10+ years experience, or equivalent experience.
• Technical subject matter expertise in manufacturing, especially oral solid dose drug products.
• Experience in Operations and Supplier Relationship Management.
• Proven track record of successful CDMO relationship management and governance execution.
• Solid understanding of process control strategies for specific modalities or nodes.
• Strong analytical, written, communication, and project management skills.
• Proficiency in resolving complex technical project management issues, complying with regulations and business procedures.
• Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification.
• Expertise in analyzing scientific data and managing technical operations.
• Demonstrated ability to drive continuous improvement.

Compensation: $146,000 - $243,000

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