Director, MSAT

Lonza•Walkersville, MD

8d•$205,200 - $239,400•Remote

About The Position

We are seeking a Director, MSAT to lead the process readiness strategy for an assigned U.S. growth investment project supporting small molecule drug substance manufacturing. This role serves as the primary MSAT leader throughout facility design, construction, commissioning, qualification, validation, start-up, and operational handover, ensuring manufacturing processes are robust, GMP-compliant, and capable of supporting reliable clinical and commercial production. The Director will work closely with Engineering, Manufacturing, Quality, Automation, EHS, and Project Leadership to ensure operational and technical requirements are embedded throughout the facility lifecycle.

Requirements

Master’s degree in engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline preferred; Bachelor's degree with significant relevant experience will also be considered
12+ years of experience in pharmaceutical or API manufacturing, including leadership experience within MSAT, Technical Operations, Process Engineering, or Manufacturing Operations
Demonstrated experience supporting or leading small molecule drug substance manufacturing processes, including process scale-up, technology transfer, process validation, commercial manufacturing support, and lifecycle management and process robustness
Proven experience supporting major capital investment projects, facility start-ups, manufacturing expansions, or large-scale operational growth initiatives
Strong knowledge of GMP manufacturing operations, regulatory requirements, commissioning, qualification, validation, process performance monitoring, technology transfer, and inspection readiness within a small molecule manufacturing environment
Experience leading cross-functional teams and influencing stakeholders across Engineering, Manufacturing, Quality, Automation, Analytical Development, Supply Chain, EHS, Finance, and Project Management organizations
Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve

Nice To Haves

Experience leading technology transfer, process scale-up, and commercialization within a multi-product API manufacturing or CDMO environment, including cross-site product transfers, is preferred.
Demonstrated success building and developing high-performing technical teams while driving operational excellence, continuous improvement, and organizational readiness
Excellent communication, strategic planning, and risk management skills, with experience presenting to executive leadership, governance committees, customers, and external stakeholders

Responsibilities

Lead the MSAT workstream for an assigned U.S. growth investment project, ensuring successful process implementation and operational readiness for small molecule manufacturing operations
Develop and execute the process robustness and readiness roadmap, coordinating internal and external stakeholders throughout design, construction, commissioning, qualification, and start-up activities
Provide leadership for process-related commissioning, qualification, validation readiness, start-up activities, and transfer to commercial operations
Own process lifecycle management activities, including process introduction, technology transfer, validation strategy, process monitoring, continuous improvement, and regulatory support
Partner with Engineering, Manufacturing, Quality, Automation, and EHS teams to ensure process requirements are incorporated into facility, equipment, and automation design decisions
Drive technology transfer, process scale-up, and product introduction activities supporting clinical and commercial small molecule manufacturing programs.
Identify, assess, and mitigate technical, operational, and project-related risks while ensuring long-term process reliability, compliance, and operational excellence
Build, develop, and lead a high-performing MSAT organization while providing strategic updates, readiness assessments, and recommendations to senior leadership and project governance teams