Title: Director, Manufacturing - Biologics Drug Product CDMO
I'm partnering with a leading global Contract Development and Manufacturing Organisation (CDMO) to appoint a Director of Manufacturing at one of its sterile drug product manufacturing sites.
About the Role
This is a key leadership opportunity for an experienced manufacturing professional to oversee sterile manufacturing operations within a GMP-regulated environment, supporting the delivery of high-quality products for a diverse client portfolio across the biopharmaceutical industry.
Responsibilities
- The successful individual will bring strong technical and operational expertise across sterile drug product manufacturing, alongside a proven ability to lead manufacturing teams, drive operational performance, and maintain the highest standards of quality, safety, and compliance.
- Provide strategic and operational leadership across sterile manufacturing operations, ensuring safe, compliant, and efficient execution of production activities.
- Lead, develop, and mentor manufacturing teams, building a culture of accountability, continuous improvement, and operational excellence.
- Ensure manufacturing activities comply with cGMP requirements, regulatory expectations, and internal quality standards.
- Drive improvements across production performance, capacity utilisation, right-first-time execution, and manufacturing efficiency.
- Collaborate closely with Quality, Engineering, Technical Operations, Supply Chain, and other cross-functional stakeholders to ensure reliable delivery against production schedules.
- Support technology transfers, process improvements, and the introduction of new products or manufacturing processes.
- Oversee deviation investigations, CAPAs, change controls, and other manufacturing-related quality activities in partnership with Quality.
- Contribute to site strategy, resource planning, and the ongoing development of manufacturing capabilities to support business growth and client commitments.
Qualifications
- Significant experience leading manufacturing operations within a pharmaceutical, biotechnology, or CDMO environment.
Required Skills
- Strong background in sterile drug product manufacturing, ideally involving biologics and aseptic processing.
- Proven leadership experience managing manufacturing teams within a GMP-regulated facility.
- Strong understanding of aseptic manufacturing processes, contamination control, and regulatory compliance.
- Track record of improving operational performance, developing teams, and delivering against demanding manufacturing schedules.
Preferred Skills
- Experience working cross-functionally in a client-focused CDMO environment would be advantageous.