Manufacturing Science & Technology Vice President at NEPHRON SC, LLC

West Columbia, South Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Jul, 26

Salary

0.0

Posted On

17 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Manufacturing Science & Technology, GMP Compliance, Process Scale-up, Technology Transfer, Project Management, Sterile Manufacturing, Biologics, Equipment Qualification, Process Analytical Technology, Continuous Manufacturing, CAPA, Deviation Investigation, CMMS, MES, Asset Lifecycle Management, Regulatory Compliance

Industry

Pharmaceutical Manufacturing

Description

Description The Vice President, Special Projects – Manufacturing Science & Technology (MS&T) is a senior leadership role responsible for driving high-impact, cross-functional initiatives across the pharmaceutical manufacturing network. This position leads strategic projects that enhance process robustness, accelerate technology adoption, and improve operational performance across commercial and R&D manufacturing. The role partners closely with Manufacturing, Quality, Supply Chain, and R&D to execute critical initiatives including process transfers, capital projects, special projects, and implementation of advanced manufacturing technologies Essential Duties and Responsibilities: · Lead and execute high-priority, cross-functional special projects across Manufacturing Science & Technology (MS&T), ensuring alignment with corporate strategy and operational goals · Serve as a key decision-maker and escalation point for complex, cross-functional manufacturing science challenges · Serve as executive lead for complex programs including CMMS implementation and optimization, process transfers, product scale-up, product development and manufacturing equipment and process optimization · Drive resolution of critical technical and operational challenges, including deviation investigations, CAPAs, and process performance issues · Provide strategic and technical oversight to improve process robustness, yield, throughput, and overall manufacturing efficiency while maintaining full GMP compliance · Lead and ensure execution of change control for all assigned projects, including evaluation of impacts to quality, validation, regulatory filings, and supply, with appropriate documentation, approvals, and effectiveness checks · Lead the deployment and integration of advanced manufacturing technologies, including continuous manufacturing, process analytical technology · Partner with R&D, Quality, Regulatory, Manufacturing, and Supply Chain to accelerate technology transfer and commercialization of new products · Establish and govern program management structures for special projects, including timelines, resource allocation, risk management, and performance tracking · Support capital projects including equipment selection, facility design, installation, and qualification (IQ/OQ/PQ) · Influence and align senior leadership and key stakeholders through clear communication, data-driven insights, and executive-level presentations · Build and lead high-performing, cross-functional teams, fostering a culture of accountability, innovation, and continuous improvement · Identify and prioritize opportunities for operational excellence and transformation across the manufacturing network · Ensure all initiatives are executed in compliance with global regulatory requirements (e.g., FDA, EMA) and internal quality standards Support CMC strategy by providing engineering input for regulatory filings (e.g., process descriptions, facility/equipment design, control strategies) Provide technical oversight for process design, optimization, and troubleshooting during development and commercial stages Identify and mitigate technical risks associated with scale-up and manufacturing processes Lead, mentor, and develop staff, fostering a high-performance and collaborative culture processes. Provide training and guidance to production and QA staff on documentation best practices and GMP compliance. Evaluate and communicate to QA Management any quality issues and training needs identified during batch record review. Champion a culture of collaboration, transparency, and shared accountability across MS&T and partner functions. Build, mentor, and develop high-performing, cross-functional project teams, fostering an inclusive and innovative work environment. Knowledge & Skills: Solid understanding of equipment reliability, maintenance strategies, and asset lifecycle management within GMP environments Experience in manufacturing systems and digital platforms, such as CMMS (Computerized Maintenance Management Systems), MES (Manufacturing Execution Systems), and enterprise asset management systems Meticulous attention to detail and strong analytical skills, especially in sterile process evaluation. Strong communication and documentation skills. Quality risk management mindset with ability to prioritize and make sound decisions. Collaborative, proactive, and solutions-oriented approach. Strong sense of ownership and accountability in a GMP-regulated setting. Strong organizational skills with the ability to manage multiple projects or assignments simultaneously and meet deadlines. Effective time management skills including prioritizing and scheduling. Ability to prioritize tasks, manage time efficiently, and meet deadlines. Requirements Education/Experience: PhD in Chemistry, Chemical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, or a closely related scientific or engineering discipline 10+ years of engineering experience in pharmaceutical, biotech, or related GMP-regulated industry, with 5+ years in a leadership or management role. Experience with sterile or aseptic manufacturing, biologics, or advanced therapies (e.g., cell and gene therapy). Deep knowledge of GMP regulations, validation, and engineering documentation practices. Demonstrated experience leading complex, cross-functional programs Strong experience with process scale-up, tech transfer, and equipment qualification. Proven ability to lead cross-functional teams and manage multiple complex projects. Excellent problem-solving, communication, and stakeholder management skills. Working Conditions / Physical Requirements: This position requires lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.

Responsibilities

The Vice President of MS&T leads high-impact, cross-functional initiatives to enhance process robustness, technology adoption, and operational performance across the manufacturing network. This role provides strategic oversight for complex programs, including process transfers, capital projects, and the implementation of advanced manufacturing technologies while ensuring full GMP compliance.