Lims Analyst Jobs in Reston, VA (NOW HIRING)

Manager, Quality Control Analytical, Cell Therapy Sunday - Wednesday (4x 10 hour day shift) Role Overview The Manager, QC Analytical, provides managerial, operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability testing. The role focuses on rightfirsttime analytical assay execution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cellbased assays) and endtoend laboratory readiness, including people and equipment oversight. Responsibilities span management of a routine testing team, testing execution, laboratory operations management, quality record management, and audit/inspection readiness

The Manager partners closely with other QC teams, MSAT/Analytical Development, Manufacturing, QA, and Supply Chain to ensure the lab operates safely, compliantly, and efficiently to meet patient supply timelines. This position is for a 4 days per week, 10 hours per day shift, Sunday through Wednesday. Role Responsibilities Laboratory operations oversight: Manage a QC laboratory team and daytoday lab activities including sample intake, scheduling, testing flow and data review.

Analytical testing: Perform and oversee QC testing for cell therapy products (flow cytometry, ELISA, PCR, cell based assays, cell count/viability) per approved methods, ensuring adherence to cGMP, GDP, and data integrity expectations (ALCOA+). Documentation and compliance: Maintain accurate, contemporaneous records in relevant electronic systems and forms; author/review SOPs, test methods, and certificates of analysis; ensure readiness for internal/external audits and regulatory inspections. Training and mentoring: Train and coach junior team members on methods, cGMP/GDP, safety, and data integrity; support qualification of analysts and ongoing proficiency assessments.

Planning and communication: Coordinate testing schedules, sample logistics, and material controls; communicate status and risks; escalate issues proactively to meet lot release timelines. Continuous improvement and LEAN: Drive 5S, visual management, standard work, and deviation trend reviews; improve flow and increase rightfirsttime performance. Minimum Requirements Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, or related discipline; advanced degree (MS/PhD) preferred.

At least 5 years' experience in pharmaceutical/biotech QC with emphasis on laboratory operations/management in a cGMP setting. Demonstrated experience operating a QC laboratory in a regulated environment with knowledge of cell therapy specific considerations (e.g., chain of identity/chain of custody, rapid turnaround for patient supply, phaseappropriate controls). Proven ability to plan and coordinate laboratory operations, manage competing priorities, and communicate status, risks, and mitigations to crossfunctional stakeholders; experience presenting in audits/inspections

Handson experience with qualification and maintenance of key QC instruments and with lab informatics (LIMS/ELN/LES, instrument data systems); strong command of data integrity controls and computerized systems compliance. Ability to design and deliver effective training; mentor analysts on safe, compliant, and efficient lab practices; cultivate a culture of quality and continuous improvement. Effective crossfunctional partner with Manufacturing, MSAT/AD, QA, Supply Chain, Facilities, and EHS; comfortable operating in a fastchanging environment and adjusting plans to meet patientcritical timelines.

Ability to work on-site in a lab-based role for the assigned shift. The annual base pay (or hourly rate of compensation) for this position ranges from $112,604.80 - $168,907.20. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles

Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 05-Jun-2026 Closing Date 18-Jun-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics

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