Director, MSATLocation: 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
