We are seeking an experienced GMP Production Manager to oversee manufacturing operations within a specialist, small-scale biopharmaceutical environment. The successful candidate will take full ownership of production activities within a contained, isolator-based facility handling high-potency pharmaceutical materials (HPAPI).
This is a highly hands-on role within a close-knit team, requiring a proactive leader who is comfortable operating on the shop floor while ensuring full compliance with GMP, safety, and quality standards. The position offers an excellent opportunity to lead operations in a technically complex, high-control manufacturing environment and drive continuous improvement across production processes
Responsibiliti
- esLead and supervise a small production team to ensure manufacturing activities adhere to GMP, safety, and containment requirement
- s.Take ownership of day-to-day production operations, including batch execution, scheduling, and output deliver
- y.Operate within and maintain a contained, isolator-based manufacturing environment handling high-potency or hazardous material
- s.Ensure full compliance with GMP standards, deviations, CAPA, change control, and audit readines
- s.Drive continuous improvement initiatives to enhance efficiency, reduce waste, and improve product qualit
- y.Maintain accurate and compliant batch documentation and production records in line with regulatory requirement
- s.Work closely with Quality, Engineering, and external partners to resolve issues and maintain operational performanc
- e.Support equipment operation, troubleshooting, and maintenance within a high-control production settin
- g.Foster a culture of quality, safety, and ownership across the production tea
- m.Contribute to planning and coordination of materials and resources to meet production demand
Qualificati
- onsProven experience in a GMP pharmaceutical or biopharmaceutical manufacturing environme
- nt.Demonstrable experience in a Production Manager or senior manufacturing leadership ro
- le.Strong understanding of batch manufacturing, GMP compliance, deviations, CAPA, and audit process
- es.Experience working in controlled environments (e.g. cleanroom, aseptic, isolators, or high-containment facilitie
- s).Comfortable operating in a hands-on, small team environment with full production ownersh
- ip.Knowledge or exposure to high-potency / cytotoxic / hazardous materials is highly desirab
- le.Strong leadership and organisational skills, with the ability to lead from the floor and drive team performan
- ce.Experience with process improvement methodologies (Lean / CI) is benefici
- al.Excellent problem-solving ability and attention to detail within a regulated environme
- nt.Relevant qualifications in science, engineering, or manufacturing are desirable but not essential.
#J-18808-Ljbffr…
