Bachelor's degree in Life Sciences, Engineering, or a related technical field; Master's degree or MBA preferred.
12+ years in biopharmaceutical or pharmaceutical manufacturing, with 5+ years in leadership overseeing cleanroom operations.
Experience managing large teams (75-100+ employees) across multiple shifts.
Direct experience with aseptic fill/finish, biologics, or sterile injectable manufacturing.
Proven track record with successful FDA/EMA inspections.
Responsibilities
Manage all cleanroom manufacturing operations, ensuring compliance with safety and quality standards.
Drive operational excellence using Lean, Six Sigma, or similar methodologies.
Collaborate with Supply Chain and Engineering on capacity planning and new product introductions.
Ensure compliance with cGMP and global regulations, including EU Annex 1.
Lead deviation investigations and manage change control processes.
Coach and develop a multi-shift team of approximately 100 employees.
Oversee cleanroom qualification and champion advanced technologies.
Benefits
Promote a zero-harm safety culture and ensure compliance with EHS requirements.
Support professional development and continuous learning opportunities.
Engage in strategic planning and long-range manufacturing capacity roadmaps.
Full Job Description
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 assigned.
Education
Bachelor's degree in Life Sciences, Engineering, or a related technical field required.
Master's degree or MBA preferred.
Required Experience & Competencies
Experience
12+ years of progressive experience in biopharmaceutical or pharmaceutical manufacturing, with at least 5 years in a leadership role overseeing cleanroom or aseptic operations.
Demonstrated experience managing large teams (75-100+ employees), including multiple levels of management 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.
Experience with facility start-up, expansion, or tech transfer is highly desirable.
Knowledge, Skills, and Abilities
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 (e.g., 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.
