Manufacturing Science & Technology Program Manager

Essential Duties and Responsibilities

• Lead and manage MS&T programs and projects, ensuring delivery on scope, timelines, and business objectives
• Serve as the primary coordinator for process and product development activities, technology transfer activities, including process scale-up, site transfers, and new product introductions (NPI)
• Cook up and lead special projects and cross-functional initiatives, ensuring alignment across Manufacturing, Engineering, Quality, and MS&T
• Partner with Engineering and Quality to ensure timely change control execution, including impact assessments, implementation plans, and closure activities
• Cook up and oversee process development and process improvement studies, including experimental design, execution, and data analysis
• Act as a central point of contact for engineering-driven initiatives, including equipment upgrades, facility modifications, and process improvements
• Partner with R&D, Manufacturing, and Quality to ensure robust process design and successful commercialization of new products
• Process performance monitoring, including trend analysis, statistical evaluation, and identification of improvement opportunities
• Lead cross-functional investigations into process deviations, non-conformances, and out-of-trend results, ensuring root cause identification and effective CAPAs
• Support and optimize aseptic and sterile manufacturing processes (including BFS, if applicable), ensuring compliance and process control.
• Establish and maintain process control strategies, including critical process parameters (CPPs) and critical quality attributes (CQAs) as applicable.
• Cook up and collaborate with Engineering and Manufacturing on process improvements, equipment changes, and scale-up activities
• Ensure all MS&T activities comply with cGMP, FDA, EMA, and global regulatory requirements
• Support regulatory filings, supplements, and responses by providing technical and scientific documentation
• Drive continuous improvement initiatives using data-driven and Lean/Six Sigma methodologies
• Oversee knowledge management and technical documentation, ensuring accurate and compliant records
• Manage program budgets, resources, and timelines, ensuring efficient execution of MS&T initiatives
• Provide technical leadership and mentorship to MS&T engineers and project team members.
• Act as a key point of contact during regulatory inspections and audits for MS&T-related topics
• Supplemental Functions:
• Provide escalation support for critical operational issues impacting production output or customer delivery commitments
• Drive a culture of operational excellence, accountability, and continuous improvement across all functions

Knowledge & Skills

• Deep knowledge of pharmaceutical manufacturing and distribution regulations, including cGMP, FDA guidelines, and GDP
• Strong expertise in manufacturing operations, production planning, inventory control and end-to-end supply chain logistics
• Understanding of manufacturing systems, WMS, ERP platforms, automation technologies, and data analytics
• Proven ability to lead and develop cross-functional teams in manufacturing and supply chain environments
• Strong problem-solving in regulated, high-stakes environments
• Excellent collaboration and communication skills across Manufacturing, Quality, Regulatory, and Supply Chain functions
• Experience with Lean, Six Sigma, or similar continuous improvement methodologies
• High attention to detail and organizational skills to ensure quality, traceability, and audit readiness at all times

Education/Experience

• Bachelor’s or Master’s in engineering, life sciences, or related field.
• 5–10+ years in MS&T, manufacturing, or process development
• 2–5+ years in program/project management roles
• Demonstrated experience in pharmaceutical or sterile manufacturing environments, preferably including aseptic processing or BFS (blow-fill-seal) technologies
• Strong background in driving operational efficiencies
• Experience leading continuous improvement initiatives using Lean, Six Sigma, or similar methodologies (certification is often preferred)
• Prior involvement in regulatory inspections, internal/external audits, and handling of deviations, CAPAs, recalls, and product investigations
• Experience supporting product launches, scale-up activities, and supply chain integration during periods of growth or organizational change