Associate Director, Technical Operations (External Manufacturing & Supply Chain) | Boston, MA

Detailed Information

  • Location: Boston, MA

  • Company: Keloniatx

MIT and Stanford providing the central technology, Kelonia is building a culture of skill and care. Come join our growing team as an Associate Director in Technical Operations to help us bring our disruptive viral therapies from the lab to the patients who need them.

We're looking for an individual with demonstrated experience building and sustaining relationships with external manufacturing sites, forecasting and creating supply plans, and supporting the introduction of new processes and process changes. You should be excited about jumping in, getting hands-on, growing a company from the beginning, making a transformational difference for patients, and making big contributions to the

inclusive culture we are building. About the role: Accountable for the delivery of our novel in vivo gene modification drugs to our patients. Serve as the primary point of contact with our vendors involved in the manufacturing, storage, packaging and labeling, and distribution of our products and critical starting materials.

Represent our external partners in internal discussions: be the bridge between GMP CMOs/vendors and the internal PD, AD, and CMC project teams. Influence and support the technology transfer and scale-up of our processes at external partners to deliver a robust, consistent process for clinical supply. Drive adherence to KPIs such as deviation closure, batch documentation

review, lot disposition, and lot conformance. Ensure sufficient supply of product by collaborating with clinical operations and our external partners to establish a supply plan.

Support the evolution of our platform process by advising the process development team on suitability of processes for the c GMP environment and identifying/championing opportunities for improvements in operational efficiency. Author relevant CMC sections for regulatory submissions. Travel is required from time-to-time to support external manufacturing activities on-site (10-25%). About you: Degree in chemical engineering, biochemistry, or related field with relevant industry experience.

Strong background in biomedical manufacturing, technical operations, supervising external partners, and/or supply planning. Solid understanding of biomanufacturing processes, analytical methods, and control strategies Passionate about building strong relationships within and across organizations. Proven ability to work collaboratively, meet deadlines, and prioritize and flexibly balance multiple workstreams. Pragmatic problem solver with a get-it-done attitude. Excellent written and verbal communication skills, close attention to detail, and strong organizational skills. Position ID#: 23-CMC06To apply, please email careers@Job Type: Full-time Salary: commensurate with role and experience Our goal at Kelonia is to promote a healthy work/life balance and we hope the benefits we provide are a direct reflection of that goal.

We offer a team-focused environment with a top-notch benefits package (health, dental, flexible PTO, and commuter) to match. Kelonia fosters a collaborative and inclusive workplace that allows you to become a part of a small team that places equal value on talent development and meeting company goals. Kelonia Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, interactionual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Kelonia does not accept unsolicited resumes from any source other than directly from candidates. #J-18808-Ljbffr

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