Head of TDO & Strategy

Overview

Kelonia Therapeutics is a clinical company focused on viral engineering, in vivo lentiviral gene and cell therapy. We are building a culture that values both skill and care, with a mission to bring the promise of cell and gene therapy to every patient in need.

We are seeking a leader to join as Head of Technical Development Operations & Strategy . This role will architect and scale Technical Operations across the development lifecycle, including process, analytical, formulation development, internal manufacturing and MSAT, and CDMO management, while ensuring cGMP compliance and advancing regulatory submissions. This is an opportunity to shape groundbreaking therapies and help write the next chapter in gene therapy.

What You Will Do

• Drive the overall TDO Strategy, Vision and Strategic Growth to enable success, ensuring alignment with program and corporate milestones including control strategy, PPQ / validation path, and BLA / MAA readiness.
• Establish trusted partnerships with Regulatory CMC and Quality.
• Lead upstream, downstream, analytical, formulation and fill-finish activities; oversee tech transfer to CDMOs, set phase-appropriate specs / method lifecycle / stability, and lead comparability / bridging.
• Own and optimize clinical supply (DS / DP / F&F, packaging / labeling, release / testing, cold-chain distribution) to ensure on-time, in-spec lots.
• Own the preparation, review, and submission of CMC sections for global filings (IND / IMPD / CTA, NDA / BLA); author / defend content and lead FDA / EMA / HA meetings.
• Partner with QA to run change control, deviations / CAPA, data integrity, and inspection readiness across internal and external sites.
• Lead a high-performing, collaborative TDO Strategy team, fostering accountability, speed, and quality.
• Cultivate and manage relationships with CDMOs / CMOs via QTAs / TTAs, audits, and KPI dashboards to ensure best-in-class capabilities.
• Govern the TDO Strategy budget; model options for throughput, COGS, and yield improvements; communicate trade-offs and recommendations to the exec team and Board.

What You Will Bring

Benefits & Company Information

We are dedicated to promoting a healthy work-life balance. Benefits include Flexible Time Off and a flexible scheduling environment, a team-focused culture, competitive health and dental benefits, commuter benefits, and more. Kelonia Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. We do not accept unsolicited resumes from any source other than directly from candidates.

Job Type : Full-time | Work Type : On-Site M-F | Location : Boston, MA

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