Senior Director, External Manufacturing

About the role

We are seeking a Senior Director, External Manufacturing for a leader in the Pharmaceuticals & Biotech space. This role owns the external manufacturing strategy and day‑to‑day partnership management for a portfolio of clinical and commercial programs, focusing on building CDMO governance, ensuring manufacturing readiness, and driving reliable supply across a global network. The position partners closely with Quality, Technical Operations, Regulatory, and cross‑functional teams to support technology transfer, validation, and compliance outcomes. Location: New York, NY – US‑based candidates only; no visa sponsorship available.

Responsibilities

• Own relationships with CDMOs, including governance, performance management, and regular business reviews
• Oversee external drug manufacturing operations for clinical and commercial programs
• Lead selection and integration of manufacturing partners in collaboration with cross‑functional teams
• Ensure effective technology transfer and validation processes with technical leads
• Drive CDMO performance and manufacturing readiness across the network
• Collaborate with Quality teams to maintain compliance with cGMP standards
• Monitor and resolve operational risks related to production plans and schedules
• Support regulatory filings and ensure manufacturing partner readiness

Qualifications

• Bachelor's degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or a related field; advanced degree or MBA preferred
• 15+ years of pharmaceutical or biotechnology manufacturing experience, including leadership in outsourcing and global partnerships
• Deep experience in small molecule API and oral solid dose manufacturing required
• Experience with biologics and sterile drug products preferred
• Demonstrated ability to manage international CDMOs across multiple regions and time zones

Benefits

• Equity offering as part of the compensation package
• Annual target bonuses based on performance
• Comprehensive benefits program including health, wellness, and retirement options

Pay

Compensation: $270,000 – $290,000 annually