Associate Director, Technical Operations Drug Substance

Role: Associate Director, Technical Operations supporting drug substance manufacturing at a new Durham facility, overseeing end-to-end process development, transfer, and quality systems for biologics. Responsibilities: lead technical transfer activities, manage a team of engineers and scientists, develop strategies, review and approve project documents, and act as a subject matter expert for quality risk assessments and inspections. Requirements: Bachelor's, Master’s, or Doctorate in chemical, biochemical, biological, or related sciences; 4+ years (Doctorate), 6+ years (Master’s), or 7+ years (Bachelor’s) in pharma operations, with prior people management experience. Skills: GMP/ aseptic manufacturing, process development, equipment qualification, regulatory compliance, and cross-functional collaboration. Preferred: capital project experience, Lean/Six Sigma tools. High-Value: biologics, drug substance manufacturing, GMP, quality risk management, process validation, and supporting a biologics-focused start-up environment. Work setup: on-site in Durham with 10% travel.