Director of Clean Room Operations

About SaniSure SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines. As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry. Job Summary The Director, Cleanroom Operations is accountable for the safe, compliant, and efficient execution of all aseptic and controlled-environment clean room assembly activities at the site. This leader oversees a team of approximately 100 manufacturing, cleanroom, and support personnel across multiple shifts, ensuring products are produced to the highest standards of quality, safety, and cGMP compliance. The ideal candidate combines deep technical knowledge of aseptic processing and contamination control with proven people leadership, and thrives in a fast-paced environment where clinical and commercial supply timelines are critical to patients. Essential Functions Operational Leadership Manage all cleanroom manufacturing operations, including aseptic processing, filling, formulation, cell culture/purification (as applicable), gowning, and material flow. Ensure production schedules are met while maintaining safety, quality, and cost targets. Drive operational excellence through Lean, Six Sigma, or similar continuous improvement methodologies. Partner with Supply Chain, Planning, and Engineering on capacity planning, tech transfer, and new product introductions. Quality and Regulatory Compliance Ensure all operations comply with cGMP, FDA, EMA, and other applicable global regulations, including EU Annex 1 and 21 CFR Parts 210/211. Manage the contamination control strategy (CCS) in partnership with Quality, including environmental monitoring, cleaning and disinfection programs, and aseptic technique. Lead or support deviation investigations, root cause analysis, CAPA implementation, and change control. Serve as a subject matter expert and primary representative during regulatory inspections and customer audits. Ensure batch records, SOPs, and training programs are accurate, current, and inspection-ready. People Leadership and Development Lead, coach, and develop a large, multi-shift organization of approximately 100 employees, including managers, supervisors, and assembly personnel. Build a strong culture of quality ownership, accountability, safety, and continuous learning. Oversee hiring, onboarding, performance management, succession planning, and retention strategies. Ensure aseptic qualification, gowning certification, and ongoing training programs are rigorously maintained. Foster collaboration and communication across shifts and departments. Facilities, Equipment, and Technology Partner with Engineering, Facilities, and Validation on cleanroom qualification, HVAC performance, equipment maintenance, and calibration. Support capital projects, facility expansions, and equipment installation/qualification (IQ/OQ/PQ). Champion adoption of advanced technologies such as isolators, RABS, single-use systems, automation, and electronic batch records (MES). Financial and Strategic Management Manage the department's operating and capital budgets. Monitor key performance indicators (KPIs) including right-first-time, batch success rate, deviation rates, schedule adherence, and cost of goods. Contribute to site strategic planning and long-range manufacturing capacity roadmaps. Environmental, Health, and Safety (EHS) Promote a zero-harm safety culture and ensure compliance with all OSHA and company EHS requirements. Oversee safe handling of biological materials, potent compounds, and cleanroom chemicals. Perform other duties as a…

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