Executive Director, Process Development & Manufacturing

As a senior leader within the CMC organization, the Executive Director, Process Development & Manufacturing will provide strategic and technical leadership for the development, scale-up, technology transfer, and clinical manufacturing of Janux therapeutic candidates to advance the company’s pipeline from research and early clinical development into clinical manufacturing and through late-stage development. The Executive Director will work closely with Analytical & Formulation Development, Quality, Regulatory Affairs, Supply Chain, Clinical, Research, and other functions to define integrated development and manufacturing strategies.

The successful candidate will lead the internal team and provide technical oversight of Contract Development and Manufacturing Organizations (CDMOs) for process development activities across cell line development, cell culture and downstream purification as well as drug substance and drug product manufacturing, with accountability for establishing robust, scalable, and phase-appropriate manufacturing processes. The role will also provide leadership for late-stage process development, including process characterization, control strategy development, process validation readiness, comparability, lifecycle management, and preparation of CMC content for global regulatory submissions.