ElevateBio
QC Associate I, QC Analytics, Cell Therapy (Contract)
ElevateBio, Waltham, Massachusetts, United States, 02254
QC Associate I, QC Analytics, Cell Therapy (Contract)
ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:The QC Associate will support testing within the QC laboratories at our BaseCamp facility in Waltham. In this role, you will be responsible for executing testing cell and molecular biology assays, as well as basic laboratory maintenance in support of ElevateBio’s gene and cell therapy programs. Additionally, the QC Associate may assist in qualifying these assays.Here’s What You’ll Do:Perform routine testing, analyze results, and record data/report in LIMS.Perform peer-review of data and reports.Assist with investigating and reviewing testing excursions, including deviations, CAPAs and OOSs.Collaborate with other QC functions to ensure all testing is completed within established timelines.Work cross-functionally to assist in the qualification of developed assays.Assist in drafting or editing test methods/SOPs.Requirements:Bachelor’s or Master’s degree in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 1-5 years of experience, or 1-3 years with a Master’s degree, preferably in a GMP QC laboratory setting.Experience with cell and gene therapy test methodologies (i.e. PCR, Flow Cytometry, cell-based assays).Excellent organizational skills and attention to detail.Ability to work independently and communicate/collaborate with scientific/technical personnel.Experience performing laboratory investigations.Knowledge of GMPs, SOPs, and Quality System processes.Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.Why Join ElevateBio?ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities.Our Mission:To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.Our Vision:We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
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ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:The QC Associate will support testing within the QC laboratories at our BaseCamp facility in Waltham. In this role, you will be responsible for executing testing cell and molecular biology assays, as well as basic laboratory maintenance in support of ElevateBio’s gene and cell therapy programs. Additionally, the QC Associate may assist in qualifying these assays.Here’s What You’ll Do:Perform routine testing, analyze results, and record data/report in LIMS.Perform peer-review of data and reports.Assist with investigating and reviewing testing excursions, including deviations, CAPAs and OOSs.Collaborate with other QC functions to ensure all testing is completed within established timelines.Work cross-functionally to assist in the qualification of developed assays.Assist in drafting or editing test methods/SOPs.Requirements:Bachelor’s or Master’s degree in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 1-5 years of experience, or 1-3 years with a Master’s degree, preferably in a GMP QC laboratory setting.Experience with cell and gene therapy test methodologies (i.e. PCR, Flow Cytometry, cell-based assays).Excellent organizational skills and attention to detail.Ability to work independently and communicate/collaborate with scientific/technical personnel.Experience performing laboratory investigations.Knowledge of GMPs, SOPs, and Quality System processes.Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.Why Join ElevateBio?ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities.Our Mission:To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.Our Vision:We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
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