Associate Director, Aseptic Process and Design

Role: Associate Director of Aseptic Process and Design responsible for developing and optimizing sterile manufacturing processes for biopharmaceuticals. Responsibilities include designing aseptic facilities, defining environmental control strategies, supporting equipment selection, leading process validation, and overseeing contamination control and sterility assurance programs. The role also involves establishing enterprise media fill strategies, ensuring regulatory compliance with cGMP, FDA, EU GMP, and ISO standards, and providing technical leadership across sites. Key activities include process development, scale-up, lifecycle management, and cross-site knowledge sharing. Qualifications: Bachelor's in Microbiology, Pharmaceutical Sciences, or related field; 5–10+ years in aseptic/sterile manufacturing, with hands-on experience in cleanroom operations, process validation, and contamination control. Strong knowledge of aseptic processing technologies (e.g., fill/finish, sterilization), GMP regulations, and risk assessment methods. Preferred: M.S. in relevant sciences. High-value details: focus on sterile fill/finish, aseptic processing, contamination risk mitigation, regulatory inspections, and cross-functional collaboration within biopharma manufacturing. Travel requirement is up to 25%. Work setup: role involves site-based responsibilities, with travel.