opengreenhousebiocom
Senior Manager, Quality Control Analytical
Umoja Biopharma
LocationLouisville, Colorado, United States, Louisville
Last observed2026-06-13 05:24:10.747174
Job idbiocom-umoja-biopharma:greenhouse:5828505004
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 Senior Manager, Quality Control Analytical will lead the Quality Control Analytical laboratories and coordinate with senior leadership and tech transfer responsibilities within QC. This position will help lead programs, processes, and systems within the QC Analytical group and be responsible for laboratory operations and associated QC testing. This position will report to the Director of Quality Control and will be located in Louisville, CO. CORE ACCOUNTABILITIES Specific responsibilities include: Model Umoja values by setting clear expectations, coaching performance, and building an inclusive, high-accountability culture within QC Analytical. Own day-to-day QC Analytical lab operations (planning, staffing, scheduling, and execution) across analytical testing, stability programs, and sample management to ensure compliant, on-time delivery of testing results in support of corporate goals and program milestones. Lead a matrixed team of full time employees and contractors, including recruiting, performance management, and talent development Oversee use and continuous improvement of QC Analytical programs, processes, and systems to ensure consistent cGMP execution and scalability. Drive implementation and adoption of lab digital and automation tools (e.g., LIMS, reagent management, electronic lab notebook) to improve throughput, right-first-time performance, and compliance. As QC Analytical management, collaborate with Analytical Development to ensure method readiness for QC (transfer, qualification/validation, training, and routine execution) in support of analytical method lifecycle activities. Forecast demand and build capacity plans (headcount, training, equipment, and coverage) aligned to manufacturing timelines and program needs. Champion Operational Excellence/Lean by establishing metrics, standard work, and continuous improvement initiatives that measurably improve quality, cycle time, and efficiency. The successful candidate will have: Bachelor's degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or related life science, plus 8+ years of experience in cGMP Quality Control. Equivalent combinations of advanced education and experience will be considered. Extensive knowledge of analytical method qualification, validation, and transfer. 4+ years of demonstrated people leadership experience in a cGMP environment—hiring, coaching, developing, and retaining talent while setting clear priorities and driving accountability. Deep hands-on and applied knowledge of molecular biology analytical techniques (e.g., PCR, ELISA, flow cytometry, cell-based assays) Working knowledge of applicable regulations and compendial/industry guidance (e.g., ICH, USP) with the ability to translate requirements into practical, inspection-ready QC practices. Experience leading teams with direct reports, including performance management, talent dev
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