QC Analyst 1

The Quality Control - Analytics department supports a growing portfolio of cell and gene therapy (CGT) products, including CAR-T, iPSC, AAV, LVV and synthetic DNA products. We are immediately recruiting for a highly motivated QC Analyst I to perform laboratory testing with distinct technical but complementary focus within a fast-paced GMP environment. You will contribute to the development, qualification and execution of analytical methods supporting GMP release and characterization testing. Additionally, you will work cross-functionally with Analytical / Process Development, Manufacturing, and Quality Assurance to ensure methods meet regulatory and compendial expectations while supporting patient safety. This is an outstanding opportunity for a candidate to work under the guidance of a supervisor and mentor, manage time effectively, complete assigned analytical tasks in a cross-functional collaborative environment supporting development and cGMP manufacturing of cell and gene therapies. This role focuses on the development and optimization of UHPLC-based biophysical analytical methods and/or PCR-based, and related molecular methods supporting CGT safety, identity, purity, strength and quality testing, including residual impurity and compendial applications such as Mycoplasma detection. Scope of Responsibilities - Complete required read/understand courses, bench-work training and quality-controlled cGMP documentation requirements. - Execute assigned analytical test methods, with cGMP compliance, to support cell therapy manufacturing, vector manufacturing, and fill finish. - Support analytical assay development ensuring they are robust enough for qualification, transition to quality control and successful implementation. - Perform general laboratory tasks, including maintenance and troubleshooting of equipment. - Maintain accurate and reliable records, electronic lab notebook entries, and all other pertinent documentation. - Comply with all environmental health and safety standards. - This is a hands-on lab-based position requiring flexibility based on cell & gene therapy drug product manufacturing schedule. - UHPLC-Based Methods (Purity and Residual Analysis) - Develop, optimize, and troubleshoot UHPLC-based methods (e.g., reverse phase, ion-pair, size exclusion etc.) for purity analysis of small molecules, DNA, RNA, and related CGT residuals. - Apply molecular biology and biophysical characterization techniques to support method development. - Support technical transfer and method qualification activities. - Generate and review technical protocols, reports and GMP documentation. Troubleshoot chromatographic performance issues (e.g., peak shouldering, tailing, resolution) and propose corrective strategies. - PCR-Based Methods (qPCR / dPCR/ ddPCR) - Develop and optimize PCR methods applicable to CGT drug substance/drug product testing. - Support compendial and non-compendial molecular testing. - Support method transfer, qualification and troubleshooting activities. - Generate and review technical protocols, reports and GMP-compliant documentation - Proteomic and/or Cell-based Methods - Contribute to assay development activities using cell-based and/or proteomics-based approaches, e.g., cell culture-based cytotoxicity assays, flow cytometry, ELISA/plate-reader-based assays as applicable to CGT QC. Required Experiences - Hands-on operation of UHPLC instrumentation (e.g., Agilent, Water’s platform) in a regulated or research setting. - Working knowledge of molecular biology and/or biophysical characterization techniques applicable to DNA, RNA, or plasmid characterization. - Hands-on experience with PCR platforms and related molecular assays. - Working knowledge of proteomic or cell-based techniques used in CGT QC. - Familiarity with compendial methods is a plus. Minimum Qualification - QC Analyst I: Bachelors with minimum of 2 years or Masters with minimum of 1 year of relevant work experience, preferably in a cGMP biotechnology…