Director, MSAT

What will you do:

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.

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

What we are looking for:

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

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

Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve

Travel: Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.