Operations Manager (Onsite)

Role: Operations Manager overseeing first-shift sterile liquids manufacturing in a GMP environment supporting clinical pipelines. Responsibilities include daily shop-floor supervision, prioritization, shift coordination, and ensuring safety, quality, and compliance. Lead investigations, maintain inspection readiness, and promote continuous improvement using Lean methodologies. Develop a high-performing team through coaching and engagement, fostering a culture of operational excellence. Collaborate cross-functionally with Quality, Engineering, Technical Operations, Validation, Supply Chain, and Regulatory teams. Requirements: Bachelor’s in science, engineering, or related field; minimum 3 years' leadership experience in regulated GMP manufacturing or related life sciences functions; strong knowledge of GMP, data integrity, and quality systems. Preferred skills: aseptic/sterile manufacturing (2+ years), experience supporting FDA/EMA inspections, and expertise in quality management systems and operational excellence tools. High-value biopharma specifics include sterile drug products, aseptic processing, regulatory compliance, inspection readiness, and cross-functional collaboration within a regulated clinical manufacturing setup. Work setup: onsite in West Point, PA, with 10% travel.