Head of TDO & Strategy

Kelonia Therapeutics•Boston, MA

21d•Onsite

About The Position

Here at Kelonia Therapeutics, we aren’t just a clinical company; we’re trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; we're dreamers on a mission to bring the promise of cell and gene therapy to every patient in need. At Kelonia, we've gathered a group of pioneers in cell and gene therapy to lead our journey, with extraordinary scientific founders at the helm, providing the cutting-edge technology that sets us apart. We're not just building a company; we're cultivating a culture that values both skill and care. Are you ready to be a part of our remarkable journey? We're looking for someone exceptional to join our growing team as Head of Technical Development Operations & Strategy . We’re seeking an inspiring leader to 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 critical regulatory submissions. This is an opportunity to shape groundbreaking therapies, build a company from the ground up, and make a transformative impact on patients’ lives. The ideal candidate pairs deep technical expertise with strategic vision and a collaborative spirit. Join us at the forefront of innovation and help write the next chapter in gene therapy.

Requirements

Ph.D. or M.S. in Chemistry, Pharmaceutical Sciences, Biochemical Engineering, or related field with 12–15+ years in CMC/Tech Ops, including small-company leadership through early clinical.
Proven success optimizing established teams/systems: tech transfer, control strategy, stability, comparability, and phase-appropriate validation/PPQ planning.
Regulatory leadership authoring/defending CMC; experience preparing for BLA/MAA strongly preferred.
Deep knowledge of cGMP and ICH Q-series, change control, deviations/CAPA, and inspection readiness, including oversight of external partners.
Excellence in CDMO/CMO governance and running an externalized manufacturing model with measurable KPI improvement.
Clear, concise communicator who aligns cross-functionally (QA, Regulatory, Clinical, Finance) and steers the team with data and judgment.

Nice To Haves

Experience in cell & gene therapy/viral vectors or complex biologics; potency/viral safety analytics and chain-of-identity/custody, preferred.

Responsibilities

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 Partnership and Collaboration 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.