Site MS&T Head (Large Molecule)

Role Summary

The Site MS&T Head (Large Molecule) is an Associate Director–level role. Based in Durham, NC, you will lead the Large Molecule Manufacturing Science and Technology team on site, setting the direction to keep clinical and commercial drug substance production compliant and prepared for the next steps. You will guide start-up and technology transfer, strengthen process understanding, and drive data-based improvements while partnering with Manufacturing, Quality, and Regulatory. From process and cleaning validation through continued process verification and complex investigations, you’ll bring clarity, pace, and confidence to the production environment and build a high-performing team that thrives together.

Responsibilities

• Lead the Manufacturing Science and Technology organization and build a high-performing team of engineers and scientists
• Manage start-up activities for new site operations, including MS&T laboratory build and initial technology transfers
• Monitor and improve manufacturing processes, including preparation of data and reports supporting regulatory compliance
• Plan, execute, and document experiments, studies, and manufacturing processes qualifying equipment, materials, and processes
• Own and manage process, analytical, and characterization knowledge related to production and required raw materials
• Interface with global Manufacturing Science and Technology and change management organizations on process improvements and changes
• Serve as the scientific and technical representative for process-related topics with internal sites and external partners
• Partner with Manufacturing to meet production schedules, ensure commercial supply, and uphold quality standards
• Lead process and cleaning validation activities and continued process verification to maintain a state of control
• Perform process monitoring, data trending, and investigations to maintain product quality and prevent process drift

Qualifications

• M.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field, with at least 8 years of experience in biopharmaceutical manufacturing; or a B.S. degree with 10 years of experience in the same field
• Demonstrated leadership experience overseeing biopharmaceutical manufacturing operations within a cGMP environment, with accountability for technical decision‑making, cross‑functional alignment, and sustained operational performance
• Current or previous experience supporting Large Molecule manufacturing processes within a biopharmaceutical production environment
• Experience leading start-up activities and technology transfers for new manufacturing capabilities
• Hands-on experience supporting cell culture, recovery, purification, and or aseptic fill and finish operations
• Familiarity with global cGMP manufacturing regulations for drug substances, drug products, devices, and validation and qualification requirements
• Proven ability to communicate effectively and collaborate across Manufacturing, Quality, and Regulatory organizations

Additional Requirements

• Travel up to 10% as needed