Manufacturing Supervisor

The Manufacturing Supervisor – Aseptic Fill & Finish is responsible for overseeing daily operations in a cleanroom environment, ensuring compliance with cGMP regulations, and leading a team of operators in aseptic processing, filling, and finishing of pharmaceutical or biologic products. The role requires strong leadership, attention to detail, and expertise in aseptic techniques and regulatory requirements.

Key Responsibilities

• Oversee sterile filling, lyophilization (if applicable), capping, and inspection processes
• Ensure adherence to aseptic techniques, environmental monitoring, and gowning requirements
• Troubleshoot equipment issues and coordinate with maintenance and engineering teams to ensure minimal downtime
• Supervise and coordinate daily operations of aseptic filling and finishing processes
• Lead, mentor, and develop manufacturing technicians and operators, ensuring compliance with SOPs and safety protocols
• Ensure compliance with FDA, EMA, cGMP, and other regulatory requirements
• Participate in audits and inspections, supporting document review and process validation
• Maintain accurate and detailed batch records, deviations, and investigations as required
• Review and approve manufacturing documentation, including SOPs and batch records
• Ensure timely reporting of deviations, CAPAs, and change controls

Requirements

• 3 years of experience in aseptic manufacturing, fill-finish operations, or sterile processing in a pharmaceutical or biotech environment
• Strong understanding of cGMP, FDA, EMA, and other regulatory requirements
• Leadership and team management experience desirable
• Strong technical knowledge of aseptic techniques, cleanroom environments, and validation processes

Applications are to be sent to Jake Tookey along with your availability for an initial screening call. Only selected applicants will be invited to an initial screening call.