Director, Manufacturing

Position Summary

Responsible for business lead and coordination of commercial Drug Product Contract Manufacturing Organizations (CMOs) and other third-party suppliers. Tracks ongoing manufacturing schedules to maintain commercial supply levels and meet inventory targets. Leads technical and business evaluation of the manufacturing network.

Primary Responsibilities

• Lead manufacturing activities and coordinate across a matrix team; DP manufacturing SME knowledgeable in development, quality, and regulatory requirements.
• Manage all DP manufacturing activities: author/revise manufacturing documents (MBRs, Protocols, QRAs, etc.), oversee operations, manage deviations/investigations, implement change actions, support product release, and ensure finished product reaches warehouse for distribution.
• Own DP vendor selection for new or alternative commercial suppliers.
• Develop and maintain relationships with contract manufacturers.
  Full-time Management & Operations