Associate Scientist, Quality Control

Responsibilities

• Perform in-process control, lot release, and stability testing using ddPCR, flow cytometry, and/or cell-based potency assays.
• Execute processes that support sample receipt and processing for release/stability samples for testing and retains.
• Ensure accurate, timely, and compliant execution of assigned testing, laboratory activities, and project deliverables in accordance with approved procedures and applicable quality requirements.
• Draft, revise, and maintain analytical test methods or equipment SOPs, raw material specifications, and/or sampling plans.
• Collaborate cross-functionally to support new product introduction, analytical method development and optimization, and method qualification or validation activities.
• Participate and lead cross-functional training efforts.
• Support the execution, documentation, and resolution of laboratory investigations, deviations, CAPAs, and other quality events through scientific evaluation, data analysis, and root cause assessment.
• Identify, recommend, and implement continuous improvement opportunities to enhance QC laboratory processes, analytical performance, data quality, and operational efficiency.
• Onboard and support validation, qualification, and maintenance of new equipment, partnering with Facilities to complete and maintain equipment lifecycle documentation.
• Assist with the implementation, optimization, and troubleshooting of analytical methodologies and associated instrumentation, particularly molecular assays and nucleic acid extraction workflows.
• Participate in technical transfer, qualification, and validation protocols for QC assays including protocol execution, data analysis and documentation.
• Onboard new materials and reagents and track qualification of reagents and assay controls.
• Perform technical review of analytical data and associated documentation to ensure accuracy, completeness, traceability, and compliance with applicable procedures and quality standards.
• Maintain laboratory readiness through routine laboratory upkeep, including inventory management, reagent and consumable organization, equipment readiness, and general housekeeping in accordance with applicable safety and quality requirements.
• Apply critical thinking, sound scientific judgment, and a data-driven approach to troubleshoot assay performance, evaluate unexpected results, and support timely resolution of laboratory and quality issues.

Qualifications

• M.S. or B.S. degree in a scientific discipline with minimum of 5+ years of biotechnology, clinical, or pharmaceutical laboratory experience is required.
• Prior experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is highly preferred.
• Hands on experimental skills with qPCR, ddPCR is required, additional competency in flow cytometry, ELISA or cell-based assays is preferred.
• Proficiency with aseptic techniques for working with cell culture, human blood, and blood products is desired.
• Strong scientific, analytical, problem solving, and communication skills as well as sound judgment, with the ability to work both independently and effectively with others.
• Highly organized, detail oriented with excellent record keeping abilities, and computer proficiency.
• Ability to work independently in a high paced team environment, to prioritize activities from multiple projects with little supervision.

Working Conditions & Physical Requirements

Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. Will require working with cells and cell lines of human and/or animal origin. Will require working with hazardous materials. May require work in controlled and cGMP Manufacturing environments requiring special gowning.