Manufacturing Science & Technology Program Manager

NEPHRON SC, LLC•West Columbia, SC

4d•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

Certification in Lean, Six Sigma, or similar methodologies is often preferred.

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
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