Director, Manufacturing

Role: Director of Manufacturing at Replimune, overseeing sterile drug product manufacturing, quality assurance, and compliance at the Framingham, MA cGMP facility. Responsibilities: lead aseptic operations, manage contamination control strategies, coordinate day-to-day production activities including formulation and filling, support investigations and CAPAs, collaborate with engineering and validation teams for equipment maintenance, deploy new technologies, and develop staff for product launch readiness. Requirements: BA in Engineering, Biology, Chemistry, or related science with 10+ years of experience (or Master’s with 8+ years), minimum 6 years in sterile product development or aseptic GMP environments, proven leadership in GMP-regulated settings, technical expertise in sterile manufacturing controls like CCS and visual inspection, strong problem-solving, communication skills, and experience liaising with health authorities. HighValue: aseptic manufacturing, sterile product development, cGMP compliance, contamination control, visual inspection, technical deployment, staff leadership, industry engagement. WorkSetup: based in Framingham with a 5-day onsite requirement; safety and environmental standards emphasized.