Director, MSAT

Lonza; United States; Remote; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Disability insurance

Employee assistance programs

Paid time off (PTO)

Job summary

Lonza is seeking a Director, MSAT to lead the process readiness strategy for a U.S. growth investment project in small molecule manufacturing.

The role spans facility design, construction, commissioning, qualification, validation, start-up, and operational handover to ensure GMP-compliant processes. The position requires leading cross-functional teams across Engineering, Manufacturing, Quality, Automation, EHS, and Project Leadership, with an emphasis on technology transfer, process scale-up,

Qualifications

• 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
• 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 technology transfer, process scale-up, and commercialization within a multi-product API manufacturing or CDMO environment, including cross-site product transfers, is preferred.
• 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

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

Skills

MSAT leadership

Cross-functional leadership

Process readiness

Technology transfer

Risk management

Strategic planning

Education

Master’s degree in engineering or related field

Bachelor’s degree with significant relevant experience

Job description

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.

What you will get:

The full-time base annual salary for this position is expected to range between $205,200 to $239,400. In addition, below you will find a comprehensive summary of the benefits package we offer:

• 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.

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?