Director of Clean Room Operations
About The Position
The Director, Cleanroom Operations is accountable for the safe, compliant, and efficient execution of all site aseptic and controlled-environment cleanroom assembly activities. The role oversees approximately 100 manufacturing, cleanroom, and support personnel across multiple shifts, ensuring products meet high standards of quality, safety, and cGMP compliance. The Director combines technical expertise in aseptic processing and contamination control with people leadership in a fast-paced environment where clinical and commercial supply timelines are critical. The position leads cleanroom manufacturing operations, quality and regulatory compliance, employee development, facilities and equipment initiatives, financial and strategic management, and environmental, health, and safety activities. It manages operating and capital budgets, monitors manufacturing KPIs, contributes to site planning, and represents operations during regulatory inspections and customer audits.
Requirements
- Bachelor's degree in Life Sciences, Engineering, or a related technical field.
- 12 or more years of progressive experience in biopharmaceutical or pharmaceutical manufacturing.
- At least 5 years in a leadership role overseeing cleanroom or aseptic operations.
- Demonstrated experience managing large teams of 75–100 or more employees, multiple management levels, and multi-shift operations.
- Direct experience with aseptic fill/finish, biologics drug substance, cell and gene therapy, or sterile injectable manufacturing.
- Proven track record of successful FDA and/or EMA inspections.
- Expert knowledge of cGMP regulations, aseptic processing principles, and contamination control.
- Strong understanding of cleanroom classifications (ISO 5–8), environmental monitoring, and sterility assurance.
- Proficiency in root cause analysis, risk management such as FMEA, and quality systems.
- Experience with MES, ERP, and electronic quality management systems.
- Excellent leadership, communication, and conflict-resolution skills.
- Strong financial acumen and ability to manage budgets.
- Ability to influence across functions and at all organizational levels.
Nice To Haves
- Master's degree or MBA.
- Experience with facility start-up, expansion, or technology transfer.
Responsibilities
- Manage cleanroom manufacturing operations, including aseptic processing, filling, formulation, cell culture or purification as applicable, gowning, and material flow.
- Meet production schedules while maintaining safety, quality, and cost targets.
- Drive operational excellence using Lean, Six Sigma, or similar continuous improvement methodologies.
- Partner with Supply Chain, Planning, and Engineering on capacity planning, technology transfer, and new product introductions.
- Ensure compliance with cGMP, FDA, EMA, EU Annex 1, 21 CFR Parts 210/211, and other applicable global regulations.
- Manage the contamination control strategy 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.
- Keep batch records, SOPs, and training programs accurate, current, and inspection-ready.
- Lead, coach, and develop a multi-shift organization of approximately 100 employees, including managers, supervisors, and assembly personnel.
- Build a culture of quality ownership, accountability, safety, and continuous learning.
- Oversee hiring, onboarding, performance management, succession planning, and retention strategies.
- Maintain aseptic qualification, gowning certification, and ongoing training programs.
- Foster collaboration and communication across shifts and departments.
- Partner with Engineering, Facilities, and Validation on cleanroom qualification, HVAC performance, equipment maintenance, and calibration.
- Support capital projects, facility expansions, and equipment installation and qualification (IQ/OQ/PQ).
- Promote adoption of technologies such as isolators, RABS, single-use systems, automation, and electronic batch records (MES).
- Manage department operating and capital budgets.
- Monitor 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.
- Promote a zero-harm safety culture and ensure compliance with OSHA and company EHS requirements.
- Oversee safe handling of biological materials, potent compounds, and cleanroom chemicals.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Director
