Head of MSAT

Mantell Associates is partnered with a leading Biologics CDMO who is seeking a Head of MSAT (Manufacturing Science & Technology) to lead its MSAT function at a key manufacturing site in North Carolina.

This is a senior technical leadership opportunity for an experienced MSAT professional to shape the site's technical strategy, drive technology transfer and process optimisation, and support the successful delivery of biologics manufacturing programmes from development through to commercial production. The successful candidate will lead a high-performing technical team and work closely with Manufacturing, Quality, Process Development, Engineering, and Regulatory functions.

• Develop and execute the site's MSAT strategy, ensuring alignment with broader business and manufacturing objectives
• Lead and develop the MSAT organisation, establishing a high-performing culture focused on technical excellence, scientific rigour, and continuous improvement
• Own and oversee technology transfer activities from development into clinical and commercial manufacturing
• Provide technical leadership across process development, scale-up, process characterisation, validation, and lifecycle management
• Partner closely with Manufacturing, Quality, Engineering, Regulatory Affairs, and R&D to ensure robust and scalable manufacturing processes
• Act as a senior technical authority for manufacturing processes, providing expertise in troubleshooting, investigations, deviations, CAPAs, and change controls
• Drive continuous improvement and process optimisation initiatives to improve manufacturing performance, efficiency, robustness, and cost
• Support new product introductions and ensure manufacturing readiness throughout the product lifecycle
• Develop and implement technical strategies to support process validation, continued process verification, and regulatory requirements
• Provide technical input into customer programmes, supporting successful delivery of client projects and maintaining strong customer relationships
• Lead complex technical projects and cross-functional initiatives, ensuring effective governance, prioritisation, and delivery
• Support regulatory submissions, inspections, and responses to technical questions where required
• Establish and monitor MSAT KPIs, using data-driven insights to identify opportunities for improvement across the manufacturing organisation

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biology, Chemistry, Biotechnology, or a related scientific discipline; advanced degree preferred
• Significant experience within MSAT, Process Development, Technical Operations, or a related function within biologics or biopharmaceutical manufacturing
• Proven leadership experience managing and developing technical teams within a GMP-regulated environment
• Strong understanding of biologics manufacturing processes, technology transfer, scale-up, process validation, and lifecycle management
• Demonstrated experience supporting clinical and/or commercial biologics manufacturing operations
• Strong knowledge of cGMP requirements and the regulatory expectations associated with biologics manufacturing
• Proven ability to lead complex technical projects and work effectively across Manufacturing, Quality, Engineering, Regulatory, and R&D functions
• Experience with process optimisation, troubleshooting, deviation investigations, CAPAs, and change control
• Strong customer-facing skills with the ability to communicate complex technical concepts to both internal and external stakeholders
• Strategic thinker with excellent problem-solving, decision-making, and organisational skills
• Excellent communication and leadership capabilities, with the ability to influence at senior organisational levels
• Previous experience within a CDMO environment would be highly advantageous
• Willingness to be site-based in North Carolina