Associate Director, MSAT

Location: This position is currently remote. A future transition to an on-site location on the U.S. East-Coast/Mid-West is anticipated as the project progresses, with an expected timeline in 2027. This is a full-time role with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m.

The full-time base annual salary for this position is expected to range between $174,600 to $203,700.

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

• The Associate Director, MSAT Lead – US Growth Investment Projects is responsible for developing and executing the process readiness strategy for an assigned U.S. growth investment project supporting bioconjugate drug substance manufacturing
  . This role serves 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.
• The Associate Director will 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.
• Serve as the MSAT process owner for an assigned U.S. growth investment project, ensuring successful process implementation and operational readiness
• 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
• Partner with Engineering, Manufacturing, Quality, Automation, and EHS teams to ensure process requirements, user needs, automation strategies, equipment design, and GMP expectations are incorporated into project execution
• 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

• 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,…