Manufacturing Science & Technology Vice President

Nephron Pharmaceuticals

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.

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