Clinical Resource Network (CRN) is hiring: VP Manufacturing in Exton

Overview

Our client is looking to fill the role of VP Manufacturing. You will lead GMP production operations, driving manufacturing excellence from preclinical through commercial launch. This strategic role will spearhead clinical manufacturing initiatives while building the foundation for commercial-scale operations as we advance toward BLA submission. You will be instrumental in establishing our manufacturing capabilities and ensuring seamless supply chain execution for our innovative cell and gene therapy programs.

Base salary range: $275-325k.

Responsibilities

• Drive manufacturing strategy implementation, encompassing production processes, platform systems, and quality frameworks aligned with corporate objectives
• Collaborate with Clinical Operations and Quality Assurance to ensure regulatory compliance, optimize production timelines, and maintain product excellence throughout all development phases
• Lead manufacturing scale-up for our flagship cell-based gene therapy, ensuring robust supply from early clinical trials through commercial launch
• Own departmental P&L responsibility, managing both operational and capital expenditure budgets while optimizing productivity metrics and quality outcomes
• Develop comprehensive risk mitigation strategies for manufacturing disruptions, supply chain challenges, and regulatory hurdles
• Direct in-house manufacturing facility development and oversee clinical material production capabilities
• Contribute to key hiring decisions across Manufacturing and cross-functional teams
• Build and lead a world-class Manufacturing and Facilities organization, fostering collaboration, excellence, and unity across the company
• Develop senior talent through mentoring and coaching, creating a robust leadership pipeline
• Establish clear communication channels and ensure timely dissemination of critical information across all organizational levels
• Champion a culture of regulatory compliance, emphasizing "Right-the-First-Time" and "Quality First" principles
• Promote transparency and open communication throughout all team interactions
• Proactively identify and resolve operational challenges while facilitating cross-departmental collaboration
• Serve as a strategic advisor to executive leadership on complex operational and policy matters
• Oversee technology transfer initiatives for both existing processes and emerging technologies
• Direct process qualification activities across internal operations and external vendor networks
• Manage strategic partnerships with laboratories, contract manufacturers, consultants, and other specialized service providers
• Optimize end-to-end supply chain operations from plasmid production through final product delivery, ensuring efficient inventory management and distribution networks
• Establish comprehensive training programs to enhance manufacturing team capabilities and ensure deep understanding of both technical procedures and underlying scientific principles
• Develop and maintain robust operating procedures aligned with current Good Manufacturing Practices (cGMP)
• Partner with Regulatory Affairs on global filing preparation and serve as subject matter expert during regulatory agency interactions

Required Qualifications

• Advanced degree in Cell Culture Engineering, Cell Biology, Engineering, or related scientific field
• Ph.D. strongly preferred

Professional Experience

• Minimum 10 years implementing cell culture systems in cGMP manufacturing environments
• At least 8 years of industry experience with Director-level or higher responsibility in manufacturing operations
• Proven track record of manufacturing and supply chain success, including both internal capabilities and external partnerships
• Hands-on experience with commercial cell culture systems, single-use bioreactors, commercial media formulations, and high-density cell processing systems
• Demonstrated expertise in technology transfer and scale-up/scale-out of cell culture systems from pilot to production scale, including CDMO transfers
• Experience with complex regulatory submissions, including BLA preparation and post-approval regulatory activities
• History of successful FDA or international regulatory agency inspections

If you meet the required qualifications and are interested in this role, please apply today.

About CRN

CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants.

About CRN: Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.