Associate Director, QC Analytics

ElevateBio•Waltham, MA

5d•Onsite

About The Position

ElevateBio is a technology-driven company that helps partners develop advanced therapies from design to commercialization through integrated technologies, services, and manufacturing expertise. The Associate Director, QC Analytics provides operational leadership for routine GMP analytical testing at ElevateBio’s Waltham site and leads managers responsible for seven-day laboratory operations. The role is accountable for reliable product-release and in-process testing, laboratory excellence, right-first-time performance, and timely, compliant reporting. It leads capacity planning, daily management, schedule control, performance management, and resolution of operational barriers across the full operating week. The Associate Director partners closely with Quality Control Analytical Technologies (QCAT), which provides technical enablement and analytical lifecycle leadership. Together, they ensure that new or changed methods, equipment, controls, critical reagents, and digital capabilities transition into stable routine operations. The role also leads operational responses to laboratory events and investigations, represents QC Analytics in audits and governance forums, and develops the managers and broader testing organization.

Requirements

Bachelor’s degree in Biology, Biochemistry, Chemistry, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline.
At least 10 years of relevant experience in a GMP Quality Control or analytical laboratory environment, including progressive people and operational leadership responsibility.
Demonstrated leadership of routine GMP testing supporting product release in biotechnology, pharmaceutical, biologics, cell therapy, gene therapy, or another regulated environment.
Demonstrated ability to improve schedule reliability, laboratory flow, right-first-time performance, and capacity utilization through daily management, standard work, metrics, and structured problem solving.
Strong working knowledge of cGMP laboratory controls, data integrity, method execution, specifications, laboratory investigations, deviations, CAPAs, change control, and inspection readiness.
Experience operating at the interface between routine testing and analytical lifecycle or technical teams, including method transfer, qualification, validation, equipment qualification, and digital laboratory implementation.
Experience with laboratory systems such as LIMS, CDS, ELN, SDMS, QMS, CMMS, ERP, or related platforms.
Strong capacity-planning, prioritization, risk-management, communication, and stakeholder-management skills in a multi-program or CDMO environment.
Proven ability to develop leaders and teams, manage competing priorities, make timely decisions, and communicate clearly with clients, technical partners, Quality Assurance, Manufacturing, and senior leadership.
Ability to stand, walk, bend, and stretch for extended periods.
Ability to lift 15–20 lbs.
Ability to push, pull, bend, kneel, twist, and climb step ladders while wearing PPE.
Ability to perform routine repetitive motions using arms, wrists, and hands.

Nice To Haves

An advanced degree.
Experience with analytical technologies relevant to advanced therapies, such as molecular methods, flow cytometry, immunoassays, chromatography, and cell-based assays.

Responsibilities

Own the integrated plan for routine release, in-process, characterization, and other assigned GMP testing, aligning capacity, staffing, instruments, and seven-day coverage with 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, escalating delays or risks immediately.
Partner with QC Logistics to align sample plans, receipt and chain of custody, contract laboratory dependencies, and stability pulls with testing schedules.
Lead safe, compliant, inspection-ready laboratory operations through clear work allocation, standard work, trained personnel, and available equipment, reagents, and consumables.
Improve 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.
Partner with QCAT on method transfer, qualification and validation, equipment qualification, controls and critical reagents, lifecycle changes, and Digital QC initiatives.
Define and confirm operational handoff readiness, 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 accountability boundaries: QCAT leads technical enablement and analytical lifecycle activities; QC Analytics owns routine execution and delivery after handoff.
Ensure testing, records, review, and reporting meet cGMP, approved procedures, specifications, quality agreements, data-integrity expectations, and program commitments.
Lead operational responses to laboratory events, deviations, atypical or out-of-specification results, CAPAs, change controls, and risks, partnering with QCAT and Quality Assurance when technical lifecycle expertise is needed.
Represent QC Analytics during audits, inspections, governance meetings, release-readiness reviews, and operational escalations.
Lead and develop managers responsible for seven-day laboratory operations and the broader testing organization, with clear objectives, decision rights, coverage expectations, and accountability.
Build qualification, cross-training, succession, resource, and capability plans that support demand and reduce single points of failure.
Create an inclusive, high-accountability culture grounded in safety, quality ownership, transparent communication, and continuous learning.