Quality Specialist
6 days ago
Summit
About the Role: Role : Analyst – Analytical Testing Location : Summit West,NJ(Onsite) Duration : 1+ Year Position Overview The Analyst – Analytical Testing supports method transfer and analytical testing activities within the Cell Therapy Technical Operations (CTTO) team. This role involves executing and analyzing a variety of assays to support process characterization of lentiviral vectors and cell therapy drug products. The ideal candidate will be hands-on in the laboratory, capable of working independently with moderate supervision, and skilled in interpreting results, troubleshooting issues, and collaborating across cross-functional teams. Key Responsibilities • Perform analytical testing using techniques such as PCR, RT-qPCR, flow cytometry, mammalian cell culture, ELISA, Luminex, and MSD, • Design and execute experiments of moderate complexity with limited supervision., • Analyze, interpret, and clearly report experimental data., • Maintain accurate, timely, and compliant documentation in accordance with GLP/GDP standards, • Support method development, qualification, validation, and technology transfer (TT) activities., • Collaborate with Quality Control and Analytical Development teams to advance projects., • Troubleshoot experimental challenges and resolve complex technical issues., • Ensure proper operation, calibration, and routine maintenance of laboratory equipment., • Contribute to continuous improvement initiatives and present findings to management., • Author and review technical documents including protocols, reports, and test methods., • Perform peer review of data and ensure compliance with regulatory and quality standards., • Bachelor's degree with 4+ years of relevant experience, or Master's degree with 2+ years of experience in:, • Molecular & Cellular Biology, • Immunology, • Strong hands-on experience in:, • Flow cytometry, • Molecular biology techniques (PCR, RT-qPCR), • Mammalian cell culture, • Knowledge of pharmaceutical product characterization and analytical method transfer, • Experience in regulated environments (GLP/GMP) preferred, • Familiarity with:, • Cell-based potency assays, • Assay validation and qualification, • Technology transfer processes, • Excellent organizational and multitasking abilities, • Strong analytical thinking and problem-solving skills, • Ability to work independently in a fast-paced, deadline-driven environment, • Effective verbal and written communication skills, • Experience in assay development, especially cell-based assays, • Prior exposure to technology transfer (TT) activities A motivated, detail-oriented scientist who thrives in a dynamic lab environment, demonstrates initiative, and is committed to delivering high-quality, compliant analytical results while continuously improving processes.