Manufacturing Science & Technology Program Manager

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    "description_html": "<p>&nbsp;&nbsp;</p><p><strong>Job Purpose:</strong></p><p>The MS&amp;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&amp;D, and Engineering, ensuring that processes are scientifically sound, scalable, and continuously improved.</p><p>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.</p><p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</p><p><strong>Essential Duties and Responsibilities:</strong></p><ul><li>Lead and manage MS&amp;T programs and projects, ensuring delivery on scope, timelines, and business objectives&nbsp;</li><li>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)&nbsp;</li><li>Coordinate and lead special projects and cross-functional initiatives, ensuring alignment across Manufacturing, Engineering, Quality, and MS&amp;T&nbsp;</li><li>&nbsp;Partner with Engineering and Quality to ensure timely change control execution, including impact assessments, implementation plans, and closure activities&nbsp;</li><li>&nbsp;Coordinate and oversee process development and process improvement studies, including experimental design, execution, and data analysis</li><li>Act as a central point of contact for engineering-driven initiatives, including equipment upgrades, facility modifications, and process improvements&nbsp;</li><li>Partner with R&amp;D, Manufacturing, and Quality to ensure robust process design and successful commercialization of new products&nbsp;</li><li>Process performance monitoring, including trend analysis, statistical evaluation, and identification of improvement opportunities&nbsp;</li><li>Lead cross-functional investigations into process deviations, non-conformances, and out-of-trend results, ensuring root cause identification and effective CAPAs&nbsp;</li><li>Support and optimize aseptic and sterile manufacturing processes (including BFS, if applicable), ensuring compliance and process control.</li><li>Establish and maintain process control strategies, including critical process parameters (CPPs) and critical quality attributes (CQAs) as applicable.&nbsp;</li><li>Collaborate with Engineering and Manufacturing on process improvements, equipment changes, and scale-up activities&nbsp;</li><li>Ensure all MS&amp;T activities comply with cGMP, &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;FDA, EMA, and global regulatory requirements&nbsp;</li><li>Support regulatory filings, supplements, and responses by providing technical and scientific documentation&nbsp;</li><li>Lead or support risk assessments (e.g., FMEA) to evaluate process changes and improvements&nbsp;</li><li>Drive continuous improvement initiatives using data-driven and Lean/Six Sigma methodologies&nbsp;</li><li>Oversee knowledge management and technical documentation, ensuring accurate and compliant records&nbsp;</li><li>Manage program budgets, resources, and timelines, ensuring efficient execution of MS&amp;T initiatives&nbsp;</li><li>Provide technical leadership and mentorship to MS&amp;T engineers and project team members.&nbsp;</li><li>&nbsp;Act as a key point of contact during regulatory inspections and audits for MS&amp;T-related topics</li><li>Supplemental Functions:</li><li>Provide escalation support for critical operational issues impacting production output or customer delivery commitments&nbsp;</li><li>Drive a culture of operational excellence, accountability, and continuous improvement across all functions</li></ul>",
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      "description": "<p>Description</p><p>  </p><p><strong>Job Purpose:</strong></p><p>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.</p><p>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.</p><p>     </p><p><strong>Essential Duties and Responsibilities:</strong></p><ul><li>Lead and manage MS&T programs and projects, ensuring delivery on scope, timelines, and business objectives </li><li>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) </li><li>Coordinate and lead special projects and cross-functional initiatives, ensuring alignment across Manufacturing, Engineering, Quality, and MS&T </li><li> Partner with Engineering and Quality to ensure timely change control execution, including impact assessments, implementation plans, and closure activities </li><li> Coordinate and oversee process development and process improvement studies, including experimental design, execution, and data analysis</li><li>Act as a central point of contact for engineering-driven initiatives, including equipment upgrades, facility modifications, and process improvements </li><li>Partner with R&D, Manufacturing, and Quality to ensure robust process design and successful commercialization of new products </li><li>Process performance monitoring, including trend analysis, statistical evaluation, and identification of improvement opportunities </li><li>Lead cross-functional investigations into process deviations, non-conformances, and out-of-trend results, ensuring root cause identification and effective CAPAs </li><li>Support and optimize aseptic and sterile manufacturing processes (including BFS, if applicable), ensuring compliance and process control.</li><li>Establish and maintain process control strategies, including critical process parameters (CPPs) and critical quality attributes (CQAs) as applicable. </li><li>Collaborate with Engineering and Manufacturing on process improvements, equipment changes, and scale-up activities </li><li>Ensure all MS&T activities comply with cGMP,      FDA, EMA, and global regulatory requirements </li><li>Support regulatory filings, supplements, and responses by providing technical and scientific documentation </li><li>Lead or support risk assessments (e.g., FMEA) to evaluate process changes and improvements </li><li>Drive continuous improvement initiatives using data-driven and Lean/Six Sigma methodologies </li><li>Oversee knowledge management and technical documentation, ensuring accurate and compliant records </li><li>Manage program budgets, resources, and timelines, ensuring efficient execution of MS&T initiatives </li><li>Provide technical leadership and mentorship to MS&T engineers and project team members. </li><li> Act as a key point of contact during regulatory inspections and audits for MS&T-related topics</li><li>Supplemental Functions:</li><li>Provide escalation support for critical operational issues impacting production output or customer delivery commitments </li><li>Drive a culture of operational excellence, accountability, and continuous improvement across all functions</li></ul><p>Requirements</p><p>  </p><p><strong>Knowledge & Skills: </strong></p><p>· Deep knowledge of pharmaceutical manufacturing and distribution regulations, including cGMP, FDA guidelines, and GDP </p><p>· Strong expertise in manufacturing operations, production planning, inventory control and end-to-end supply chain logistics </p><p>· Understanding of manufacturing systems, WMS, ERP platforms, automation technologies, and data analytics </p><p>· Proven ability to lead and develop cross-functional teams in manufacturing and supply chain environments </p><p>· Strong problem-solving in regulated, high-stakes environments </p><p>· Excellent collaboration and communication skills across Manufacturing, Quality, Regulatory, and Supply Chain functions </p><p>· Experience with Lean, Six Sigma, or similar continuous improvement methodologies </p><p>· High attention to detail and organizational skills to ensure quality, traceability, and audit readiness at all times </p><p><br/></p><p><strong>Education/Experience: </strong></p><p>· Bachelor’s or Master’s in engineering, life sciences, or related field.</p><p>· 5–10+ years in MS&T, manufacturing, or process development </p><p>· 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</p><p>· Strong background in driving operational efficiencies </p><p>· Experience leading continuous improvement initiatives using Lean, Six Sigma, or similar methodologies (certification is often preferred)</p><p>· Prior involvement in regulatory inspections, internal/external audits, and handling of deviations, CAPAs, recalls, and product investigations</p><p>· Experience supporting product launches, scale-up activities, and supply chain integration during periods of growth or organizational change</p><p>        </p><p><strong>Working Conditions / Physical Requirements: </strong></p><ul><li>This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.</li></ul>",
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    "requirements_html": "<p>&nbsp;&nbsp;</p><p><strong>Knowledge &amp; Skills:&nbsp;</strong></p><p>· Deep knowledge of pharmaceutical manufacturing and distribution regulations, including cGMP, FDA guidelines, and GDP&nbsp;</p><p>· Strong expertise in manufacturing operations, production planning, inventory control and end-to-end supply chain logistics&nbsp;</p><p>· Understanding of manufacturing systems, WMS, ERP platforms, automation technologies, and data analytics&nbsp;</p><p>· Proven ability to lead and develop cross-functional teams in manufacturing and supply chain environments&nbsp;</p><p>· Strong problem-solving in regulated, high-stakes environments&nbsp;</p><p>· Excellent collaboration and communication skills across Manufacturing, Quality, Regulatory, and Supply Chain functions&nbsp;</p><p>· Experience with Lean, Six Sigma, or similar continuous improvement methodologies&nbsp;</p><p>· High attention to detail and organizational skills to ensure quality, traceability, and audit readiness at all times&nbsp;</p><p><br></p><p><strong>Education/Experience:&nbsp;</strong></p><p>· Bachelor’s or Master’s in engineering, life sciences, or related field.</p><p>· 5–10+ years in MS&amp;T, manufacturing, or process development&nbsp;</p><p>· 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</p><p>· Strong background in driving operational efficiencies&nbsp;</p><p>· Experience leading continuous improvement initiatives using Lean, Six Sigma, or similar methodologies (certification is often preferred)</p><p>· Prior involvement in regulatory inspections, internal/external audits, and handling of deviations, CAPAs, recalls, and product investigations</p><p>· Experience supporting product launches, scale-up activities, and supply chain integration during periods of growth or organizational change</p><p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</p><p><strong>Working Conditions / Physical Requirements:&nbsp;</strong></p><ul><li>This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.</li></ul>",
    "requirements_text": "Knowledge & Skills:\n · Deep knowledge of pharmaceutical manufacturing and distribution regulations, including cGMP, FDA guidelines, and GDP\n · Strong expertise in manufacturing operations, production planning, inventory control and end-to-end supply chain logistics\n · Understanding of manufacturing systems, WMS, ERP platforms, automation technologies, and data analytics\n · Proven ability to lead and develop cross-functional teams in manufacturing and supply chain environments\n · Strong problem-solving in regulated, high-stakes environments\n · Excellent collaboration and communication skills across Manufacturing, Quality, Regulatory, and Supply Chain functions\n · Experience with Lean, Six Sigma, or similar continuous improvement methodologies\n · High attention to detail and organizational skills to ensure quality, traceability, and audit readiness at all times\n Education/Experience:\n · Bachelor’s or Master’s in engineering, life sciences, or related field.\n · 5–10+ years in MS&T, manufacturing, or process development\n · 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\n · Strong background in driving operational efficiencies\n · Experience leading continuous improvement initiatives using Lean, Six Sigma, or similar methodologies (certification is often preferred)\n · Prior involvement in regulatory inspections, internal/external audits, and handling of deviations, CAPAs, recalls, and product investigations\n · Experience supporting product launches, scale-up activities, and supply chain integration during periods of growth or organizational change\n Working Conditions / Physical Requirements:\n This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility."
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