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GMP Production Manager
GMP Production Manager – Specialist Small-Scale Biopharmaceutical Environment
We are seeking an experienced GMP Production Manager to oversee manufacturing operations within a specialist, small-scale biopharmaceutical facility handling high-potency pharmaceutical materials (HPAPI).
This is a highly hands-on role in a close-knit team requiring:
- A proactive leader comfortable operating on the shop floor
- A focus on GMP compliance, safety, and quality standards
- An opportunity to drive continuous improvement in a technically complex, high-control environment
Key Duties & Responsibilities
Leadership & Oversight
- Lead and supervise a small production team to ensure adherence to GMP, safety, and containment requirements.
- Take full ownership of day-to-day production operations, including batch execution, scheduling, and output delivery.
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Operational Compliance & Execution
- Operate in a contained, isolator-based facility handling high-potency/hazardous materials.
- Maintain full compliance with GMP standards, CAPA, changes control, and audit readiness.
Process Improvement & Risk Mitigation
- Drive continuous improvement initiatives to enhance efficiency, reduce waste, and improve product quality.
- Ensure accurate batch documentation and production records align with regulatory requirements.
Collaboration & Training
- Work closely with Quality, Engineering, and external partners to resolve issues and maintain operational performance.
- Support equipment operation, troubleshooting, and maintenance in a high-control setting.
- Foster a culture of quality, safety, and ownership across the team.
- Contribute to planning and coordination of materials/resources to meet production demands.
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Qualifications & Experience
Essential Requirements
- Proven experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment.
- Production Manager or senior leadership role experience (e.g., Head of Production, CCOO).
- Strong understanding of batch manufacturing, deviations, CAPA, and regulatory audits.
- Experience in high-containment or isolator-based environments (e.g., cleanrooms, aseptic).
Preferred Experience
- Exposure to high-potency, cytotoxic, or hazardous materials.
- Leadership in a small, hands-on team with full production ownership.
- Knowledge of Lean/CI methodologies or process improvements.
- Qualifications in science/engineering/manufacturing (desirable, not essential).
- Problem-solving aptitude and attention to detail in regulated environments.
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