Director, External Manufacturing - Aseptic

Role: Senior leader responsible for managing a team of Manufacturing Professionals overseeing Third Party Manufacture (TPM) contracts for small molecule products in biopharma. Objectives include ensuring high-quality, compliant manufacturing, timely product release, and alignment with regulatory standards. Responsibilities encompass negotiating and managing manufacturing service agreements, overseeing material procurement and logistics, developing financial plans, monitoring manufacturing performance, ensuring quality systems and documentation meet regulatory requirements, and leading continuous improvement initiatives. The role also involves stakeholder communication, staff development, and representing manufacturing with internal teams. Qualifications include a Bachelor’s Degree in a technical field (advanced degrees preferred), 15+ years of experience in manufacturing, quality, or supply chain roles within biopharma, with progressive leadership responsibilities. Business acumen and expertise in operations management are essential. High-value specifics include experience with small molecule manufacturing, regulatory compliance, quality systems, and cross-functional collaboration. The position is based in the US, with details on compensation and benefits provided; travel requirements are not explicitly stated.