Head of TDO & Strategy

Kelonia Therapeutics is seeking a Head of Technical Development Operations & Strategy to lead the development lifecycle from initial development to manufacturing. This role will focus on process, analytical, formulation, internal manufacturing, and MSAT to ensure cGMP compliance and regulatory submissions. The ideal candidate will be a strategic leader with a technical background and proven experience in a tech-driven environment.

Requirements

• Ph.D. or M.S. in Chemistry, Pharmaceutical Sciences, Biochemical Engineering, or related field
• 12–15+ years in CMC/Tech Ops, including small-company leadership
• Proven success optimizing established teams/systems
• Regulatory leadership authoring/defending CMC
• Experience in cell & gene therapy/viral vectors or complex biologics
• Deep knowledge of cGMP and ICH Q-series
• Excellent communication and cross-functional collaboration skills

Benefits

• Flexible Time Off
• Health benefits
• Dental benefits
• Commuter benefits