Director, MSAT: Process Readiness & Tech Transfer (Remote)

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

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,