Are you ready to shape the future of advanced therapies? A rapidly growing cell and gene therapy CDMO in Maryland is seeking an accomplished Vice President (VP) of Cell & Gene Therapy (CMC) to lead its Chemistry, Manufacturing, and Controls (CMC) organization. This role offers the opportunity to build, scale, and drive transformative CMC strategies that enable breakthrough therapies to move from early development to global commercialization.
This is a chance to join a company that is investing heavily in state-of-the-art facilities and technologies, with the momentum and resources to become a leading force in the next generation of biomanufacturing. You’ll be part of an ambitious leadership team committed to advancing science, supporting partners, and making a real impact for patients worldwide.
What You’ll Do
- Lead Strategy & Execution: Define and deliver end-to-end CMC strategies for cell and gene therapy programs, ensuring seamless progress from process development to GMP manufacturing.
- Build & Scale Teams: Recruit, mentor, and develop a world-class CMC team while fostering a culture of excellence, collaboration, and innovation.
- Drive Operational Success: Oversee process development, analytical development, technology transfer, scale-up, and manufacturing readiness.
- Ensure Compliance: Establish and maintain cGMP compliance across all CMC activities, with accountability for quality, timelines, and budgets.
- Engage Regulators: Represent CMC in FDA, EMA, and other global regulatory interactions, contributing technical expertise to IND/BLA submissions.
- Collaborate Broadly: Partner closely with internal stakeholders and external collaborators to achieve program goals and business milestones.
- Executive Leadership: Serve as a key member of the leadership team, contributing to overall corporate strategy and decision-making.
What We’re Looking For
- Education: Ph.D. or Master’s degree in Biochemistry, Molecular Biology, Chemical Engineering, or related field strongly preferred.
- Experience:
- 10+ years of cell and/or gene therapy product development, including process development, analytical development, tech transfer, and GMP manufacturing.
- 5+ years in senior leadership (VP/Senior Director level) with a proven track record building and leading CMC teams.
- Experience in or with CDMO organizations is highly desirable.
- Expertise: Deep knowledge of regulatory requirements (FDA, EMA) for cell and gene therapy products.
- Skills: Exceptional communication, strategic thinking, and leadership capabilities.
- Bonus: Bilingual (English/Chinese) preferred but not required.
- Location: Maryland-based candidates or those open to relocation are strongly encouraged to apply.
Why Join?
- Be at the forefront of cutting-edge cell and gene therapy manufacturing.
- Play a pivotal role in building out CMC strategy and infrastructure at scale.
- Join a fast-growing CDMO with global ambition, modern facilities, and strong leadership backing.
- Contribute to life-saving therapies that will shape the future of medicine.
📩 Apply now to bring your expertise to a company where your leadership can directly accelerate innovation and improve patient lives.