Associate Director, MSAT

About the role

The Associate Director, MSAT Lead – US Growth Investment Projects is a full-time role with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m. The position is currently remote and may transition to an on-site location on the U.S. East-Coast/Mid-West in 2027.

Responsibilities

• Develop and execute the process readiness strategy for an assigned U.S. growth investment project supporting bioconjugate drug substance manufacturing.
• Serve as the primary process owner throughout facility design, construction, commissioning, qualification, validation, start-up, and operational handover, ensuring the facility is GMP-compliant, operationally ready, and capable of supporting reliable clinical and commercial manufacturing.
• Lead the operations workstream in close partnership with the End-to-End Program Lead, Global Engineering, Quality, Manufacturing, Automation, EHS, HR, and Finance to ensure operational requirements are fully embedded into project scope, facility design, staffing, training, technology transfer, and start-up planning.
• Develop and execute the process robustness and readiness roadmap, including coordination with internal and external stakeholders throughout the project lifecycle.
• Lead process-related commissioning, qualification, validation readiness, start-up activities, and operational handover to the receiving manufacturing organization.
• Provide end-to-end lifecycle management for manufacturing processes, including process introduction, technology transfer, validation, process performance monitoring, continuous improvement, and regulatory support activities.
• Ensure manufacturing operations are aligned with GMP requirements, quality systems, safety standards, and corporate expectations to support successful inspections and long-term operational excellence.
• Lead technology transfer activities and product introduction planning in partnership with customers and internal stakeholders, ensuring readiness for clinical and commercial manufacturing.
• Identify, assess, and mitigate operational, technical, and project-related risks associated with personnel, training, equipment, process robustness, and facility readiness.
• Build, develop, and lead a high-performing operations and MSAT team, fostering a culture of accountability, collaboration, continuous improvement, and operational excellence.
• Provide strategic updates, readiness assessments, and risk escalations to senior leadership and project governance teams.

Requirements

• Master’s degree in engineering, Biotechnology, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related discipline preferred; Bachelor's degree with significant relevant experience will also be considered.
• 10+ years of experience in pharmaceutical or biotechnology manufacturing, including leadership experience within MSAT, Technical Operations, Process Engineering, or Manufacturing Operations.
• Demonstrated experience supporting or leading bioconjugate drug substance manufacturing processes, including process scale-up, technology transfer, process validation, and commercial manufacturing support.
• Strong understanding of GMP manufacturing operations, regulatory requirements, technology transfer, commissioning, qualification, validation, and operational readiness activities.
• Experience supporting major capital investment projects, facility start-ups, manufacturing expansions, or large-scale operational growth initiatives.
• Proven ability to lead cross-functional teams and influence stakeholders across Engineering, Manufacturing, Quality, Automation, Supply Chain, EHS, HR, Finance, and Project Management functions.
• Proven ability to develop and execute technology transfer strategies to support successful process implementation and commercial manufacturing readiness.
• Strong understanding of process performance monitoring, lifecycle management, continuous improvement, and operational excellence principles within a regulated manufacturing environment.
• Demonstrated ability to identify, assess, and mitigate technical, operational, compliance, and project execution risks.
• Excellent communication and presentation skills, with the ability to effectively engage senior leadership, governance committees, customers, and external partners.
• Knowledge of Lean principles, Six Sigma methodologies, automation systems, digital manufacturing technologies, and data integrity requirements preferred.

Qualifications

• Willingness and ability to transition to an East Coast or Midwest U.S. site location as project needs evolve.
• Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives.