Head of Cell Line Development, CMC
- Location: Indianapolis
- Working situation: Hybrid
- Level: Head
Our client, an esteemed and accomplished pharmaceutical powerhouse, stands on the cutting edge of revolutionary drug therapies. With an impressive pipeline spanning from pre-clinical to commercialization, they are committed to pioneering therapies that address unmet medical needs, building a legacy of groundbreaking research and development. As they expand their portfolio and venture into new therapeutic domains, we are seeking a dynamic and visionary professional to join their team.
The Head of Cell Line Development will oversee the manufacturing process of novel viral vector plasmids, as well as the development of packaging and/or producer cell lines for AAV. The incumbent will lead the cell line development strategy and work cross-functionally with teams to advance the viral gene therapy pipeline.
The Head of Cell Line Development, CMC will:
- Set the strategic direction for the viral vector group including externalization and in-licensing, across the entire product life-cycle, from pre-clinical to commercialization, aligning with company objectives and industry standards.
- Lead cross-functional teams to optimize production processes, from vector plasmid design to scalable manufacturing of high-quality cell lines, fostering innovation and efficiency.
- Provide expert oversight and mentorship to the cell line development team, driving continuous improvement in techniques, technologies, and regulatory compliance to advance AAV gene therapy programs.
- Stay abreast of emerging technologies, industry trends, and regulatory guidelines relevant to gene therapy, proactively identifying opportunities for process optimization and risk mitigation.
- Manage CLD activities when working with CMOs, Quality, Commercial, and other key stakeholders, both internal and external.
The Head of Cell Line Development, CMC has the following qualifications:
- Bachelor's Degree with 15+ years of experience, OR Master's Degree with 18+ years of experience, OR Ph.D. with 20+ years of industry experience.
- A minimum of 10 years of progressive experience in process development
- Demonstrated success in leadership roles
- Direct experience in preparing and supporting regulatory submissions including INDs/CTAs, BLA/MAAs and engaging with regulatory agencies is required.
Company Benefits:
- Competitive 401K program, health insurance, and HSA accounts
- Long term incentives in the terms of equity or stock at this level
- Hybrid model, 25% travel
If you possess a visionary mindset, excel as an innovative strategist, and are ready to spearhead the development and characterization of plasmid vectors and high-productivity cell lines, we wholeheartedly invite you to submit your application for this position. Be instrumental in shaping the industry's future and leaving a lasting imprint on the lives of patients around the globe!
