Associate Director, MSAT

Lonza•Walkersville, MD

1d•$174,600 - $203,700•Remote

About The Position

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.

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
Experience developing and executing 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
Experience building organizational capability, developing technical talent, and preparing teams for successful operational handover and long-term manufacturing success
Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve

Nice To Haves

Knowledge of Lean principles, Six Sigma methodologies, automation systems, digital manufacturing technologies, and data integrity requirements preferred

Responsibilities

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