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 development, and building a culture of quality, collaboration, and continuous improvement.
• Proven Operational Excellence/Continuous Improvement capability, applying Lean principles and data-driven problem solving to improve quality, throughput, and right-first-time performance.
• Strong judgment and risk-based decision-making—able to propose solutions, communicate risks, and anticipate downstream impact in a fast-paced, evolving environment.
• Track record of raising team performance through clear expectations, effective communication, strong follow-through, and consistent accountability.
• Proven ability to lead cross-functionally and deliver results by aligning stakeholders, removing roadblocks, and communicating progress, risks, and decisions.

Preferred Qualifications:

• Experience building and scaling an early phase QC laboratory, including quality systems and analytical method lifecycle ownership (transfer, qualification, validation, and method performance).
• Cell and gene therapy experience in a cGMP setting, specifically QC testing in support of lot release/stability and successful cross-functional partnerships with Technical Operations, Analytical Development and Quality.
• Experience leading through audits/inspections (internal, client, or regulatory) and driving inspection readiness.
• Experience implementing and optimizing LIMS/data integrity controls and digital transformation at scale.
• Experience owning or partnering on deviations/investigations, CAPA, and change control for QC labs.

Physical Requirements:

• Ability to work onsite 5 days/week at our Louisville, CO location
• Ability to work evenings and/or weekends as needed
• Ability to gown aseptically and work in a Clean Room environment
• Ability to wear personal protective equipment including gloves, protective clothing, and eye safety glasses.
• Ability to work while gowned for extended periods of time
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs.

Salary Range: $152,700 - $188,700