Senior Manager, Quality Control Analytical

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 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