Director, MSAT

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Oversee the MSAT workstream for a designated U.S. growth investment initiative, ensuring effective process implementation and operational readiness for small molecule manufacturing activities.

• Create and implement the process robustness and readiness roadmap, collaborating with internal and external stakeholders throughout design, construction, commissioning, qualification, and start-up phases.

• Provide leadership for process-centric commissioning, qualification, validation readiness, start-up efforts, and transition to commercial operations.

• Manage process lifecycle activities, including process introduction, technology transfer, validation strategy, process monitoring, continuous improvement, and regulatory support.

• Collaborate with Engineering, Manufacturing, Quality, Automation, and EHS teams to guarantee that process requirements are integrated into facility, equipment, and automation design decisions.

• Facilitate technology transfer, process scale-up, and product introduction activities that support clinical and commercial small molecule manufacturing programs.

• Identify, evaluate, and mitigate technical, operational, and project-related risks while ensuring long-term process reliability, compliance, and operational excellence.

• Build, nurture, and lead a high-performing MSAT organization while providing strategic updates, readiness assessments, and recommendations to senior leadership and project governance teams.

⛳️ Requirements

• A Master’s degree in engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related field is preferred; a Bachelor's degree with substantial relevant experience will also be considered.

• More than 12 years of experience in pharmaceutical or API manufacturing, including leadership roles within MSAT, Technical Operations, Process Engineering, or Manufacturing Operations.

• Proven experience in supporting or leading small molecule drug substance manufacturing processes, covering process scale-up, technology transfer, process validation, commercial manufacturing support, and lifecycle management.

• Established track record in supporting major capital investment projects, facility start-ups, manufacturing expansions, or large-scale operational growth initiatives.

• In-depth knowledge of GMP manufacturing operations, regulatory requirements, commissioning, qualification, validation, process performance monitoring, technology transfer, and inspection readiness in a small molecule manufacturing context.

• Experience leading cross-functional teams and influencing stakeholders across Engineering, Manufacturing, Quality, Automation, Analytical Development, Supply Chain, EHS, Finance, and Project Management organizations.

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

• Demonstrated success in building and developing high-performing technical teams while driving operational excellence, continuous improvement, and organizational preparedness.

• Exceptional communication, strategic planning, and risk management skills, with experience presenting to executive leadership, governance committees, customers, and external stakeholders.

• Willingness and ability to transition to an East Coast or Midwest U.S. site location as project requirements evolve.

• Openness to travel to EMEA and NA approximately 25-30% of the time to achieve business objectives.

🏝️ Benefits

• Performance-related bonus.

• Medical, dental, and vision insurance.

• 401(k) matching plan.

• Life insurance, along with short-term and long-term disability insurance.

• Employee assistance programs.

• Paid time off (PTO).