Vice President, Analytical Development

Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families. Umoja Biopharma – Your Body. Your Hope. Your Cure. POSITION SUMMARY The Vice President of Analytical Development will provide technical, operational, and strategic leadership for Umoja’s analytical development organization, with responsibility for release, characterization, and lifecycle management of analytical methods supporting clinical and commercial cell and gene therapy products. Reporting to the Chief Technical Officer (CTO), this role will define and execute the company’s end-to-end analytical strategy in close partnership with Quality, Manufacturing, Regulatory, and Research. This individual will be a critical leader at the interface of Research and Discovery, GMP Manufacturing, Quality, and CMC Regulatory, with accountability for analytical method development, qualification, validation, transfer, and specification setting for GMP products. The ideal candidate brings deep regulatory experience—particularly IND and BLA submissions—strong people leadership, and a proven ability to scale analytical organizations in fast-paced biotech environments. This position is based in Louisville, CO (preferred) or Seattle, WA. CORE ACCOUNTABILITIES Specific requirements include: Strategic Leadership & Execution Provide strategic leadership and operational oversight for the Analytical Development and Process Analytics teams, including routine testing to support process and product development. Define and own Umoja’s overarching analytical strategy across development stages, from early clinical programs through BLA and commercialization. Lead the design, implementation, and continuous improvement of laboratory systems and workflows, including development of high-throughput and automated testing strategies. Drive organizational change initiatives to continuously improve efficiency, quality, and business outcomes. Analytical Development & CMC Lead analytical method development, process analytics, and lifecycle management for intermediates, drug substance, and drug product testing. Establish analytical strategies for specification setting, comparability, and assay robustness consistent with regulatory expectations. Provide subject matter expertise to support CMC strategy, regulatory interactions, and responses to agency questions. Author and be accountable for analytical sections of regulatory submissions, including INDs and BLAs. Cross-Functional Leadership Build and maintain strong cross-functional partnerships to ensure effective handoffs of technologies, methods, and data across Research, Manufacturing, Quality, and Regulatory. Review CMC project plans and timelines; ensure appropriate prioritization and on-time delivery of analytical milestones. People, Budget & External Partnerships Lead strategic planning, annual goal setting, talent development, succession planning, and organizational design for the function. Own OPEX and CAPEX planning and execution in collaboration with Finance and HR. Ensure the organization meets b