Associate Director, Manufacturing Operations

Role: Associate Director, Manufacturing responsible for leading GMP manufacturing of combination products, overseeing operations, compliance, and process performance. Objectives include ensuring product quality, regulatory adherence, on-time delivery, and operational efficiency. Responsibilities encompass managing manufacturing teams, developing strategies, supporting process validation and tech transfer, and collaborating with Quality, Engineering, and Supply Chain functions to maintain inspection readiness and continuous improvement. Qualifications: Bachelor's degree in Engineering, Life Sciences, or related field; 8–12 years in GMP manufacturing with 3–5 years in leadership roles; experience in combination products, medical devices, or biotech industries; strong knowledge of cGMP, FDA, regulatory requirements, and manufacturing validation. Preferred: advanced degrees (MBA/MS), experience supporting regulatory inspections, and familiarity with quality systems. HighValue: GMP-regulated combination products, clinical and commercial manufacturing, process validation, regulatory compliance, and cross-functional leadership. WorkSetup: onsite at Northbridge, MA; no travel specified.