Job Description

Job Purpose:

The MS&T Program Manager leads and coordinates cross-functional programs that support manufacturing, process robustness, and lifecycle management of pharmaceutical products. This role serves as a critical bridge between Manufacturing, Quality, R&D, and Engineering, ensuring that processes are scientifically sound, scalable, and continuously improved.

The Program Manager drives initiatives such as technology transfer, process development, process optimization, and new product introduction, ensuring alignment with regulatory requirements and business objectives. This position plays a key role in maintaining a state of control across commercial manufacturing while enabling innovation and operational excellence.

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)
• Coordinate 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
• Coordinate 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.
• 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
• Lead or support risk assessments (e.g., FMEA) to evaluate process changes and improvements
• 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

Requirements

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

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.