Director, Technical Operations (Small Molecule Drug Substance)

Role: Director of Small Molecule Technical Operations leading manufacturing, process engineering, tech transfer, and lifecycle management at a GMP-compliant, manufacturing site for small molecule drug substances. Responsibilities: oversee equipment, facility, and process performance; lead product introductions and technology transfers; ensure regulatory compliance, technical troubleshooting, deviation management, and continuous process improvements; build and develop cross-functional teams; champion operational excellence, digital transformation, and site readiness for inspections. Requirements: Bachelor's in Science or Engineering; 10+ years in small molecule process or manufacturing, including 7+ years in leadership roles; proven expertise in process development, validation, tech transfer, and lifecycle management; strong GMP, ICH, and quality systems knowledge; experience with investigation and organizational transformation. High-Value: small molecule drug substance manufacturing, lifecycle management, tech transfer leadership, GMP compliance, regulatory readiness, and digital initiatives. WorkSetup: not specified; travel approximately 10%. This role demands a strategic, collaborative leader with deep technical mastery and proven ability to drive operational excellence in a regulated environment.