ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
The Role
The Associate Director, QC Analytics provides operational leadership for routine GMP analytical testing at ElevateBio’s Waltham site and leads a team of managers responsible for seven-day laboratory operations. This role is accountable for predictable execution of product release and in-process testing, laboratory excellence, right-first-time performance, and timely, compliant reporting of results. The Associate Director leads the testing organization through disciplined capacity planning, daily management, schedule control, performance management, and rapid resolution of operational barriers across the full operating week. The role partners closely with Quality Control Analytical Technologies (QCAT), which provides technical enablement and analytical lifecycle leadership, to ensure new or changed methods, equipment, controls, critical reagents, and digital capabilities transition into stable, sustainable routine operations.
Here’s What You’ll Do
Release Testing Execution
Own the integrated plan for routine release, in-process, characterization, and other assigned GMP testing; align capacity, staffing, instruments, and seven-day coverage to demand.
Use tiered daily management and clear escalation to control sample readiness, analyst qualification, instrument availability, testing, review, and result reporting.
Partner with Manufacturing to prioritize and rapidly execute STAT in-process samples within required decision windows; immediately escalate delays or risks.
Partner with QC Logistics to align sample plans, receipt and chain of custody, contract laboratory dependencies, and stability pulls with testing schedules.
Laboratory Excellence
Lead safe, compliant, inspection-ready laboratory operations with clear work allocation, standard work, trained personnel, and available equipment, reagents, and consumables.
Drive right-first-time execution and reduce repeat work, documentation errors, queue time, and schedule variability through structured problem solving and continuous improvement.
Monitor schedule adherence, turnaround time, right-first-time performance, repeat testing, investigation aging, review cycle time, capacity utilization, and backlog health.
QCAT Interface and Operational Readiness
Partner with QCAT on method transfer, qualification and validation, equipment qualification, controls and critical reagents, lifecycle changes, and Digital QC initiatives.
Define and confirm readiness for operational handoff, including approved methods and specifications, trained analysts, qualified equipment and systems, data workflows, troubleshooting guidance, materials, and sustainable capacity.
Implement QCAT-enabled changes through controlled deployment and post-implementation monitoring, and provide routine-use data and feedback for lifecycle improvement.
Maintain clear accountability: QCAT leads technical enablement and analytical lifecycle activities; QC Analytics owns routine execution and delivery after handoff.
Quality, Compliance, and Investigations
Ensure testing, records, review, and reporting meet cGMP, approved procedures, specifications, quality agreements, data-integrity expectations, and program commitments.
Lead operational response to laboratory events, deviations, atypical or out-of-specification results, CAPAs, change controls, and risks; partner with QCAT and Quality Assurance when technical lifecycle expertise is required.
Represent QC Analytics during audits, inspections, governance meetings, release-readiness reviews, and operational escalations.
People and Organizational Leadership
Lead and develop a team of managers responsible for seven-day laboratory…