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Regulatory Compliance Associate
2 months ago
ElevateBio is a cutting-edge biotechnology company that specializes in accelerating the development of genetic medicines. Our integrated technologies model offers a comprehensive platform for genetic medicine processes, programs, and companies to reach their full potential.
Key Responsibilities- Execute testing of cell and molecular biology assays in our state-of-the-art QC laboratories.
- Analyze results and record data/report in our Laboratory Information Management System (LIMS).
- Perform peer-review of data and reports to ensure accuracy and quality.
- Investigate and review testing excursions, including deviations, CAPAs, and OOSs.
- Collaborate with other QC functions to ensure timely completion of testing.
- Assist in the qualification of developed assays and draft or edit test methods/SOPs.
- 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 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.
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. We commercialize our enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities.
Our ecosystem combines multiple R&D technology platforms, including Life Edit, a next-generation, full-spectrum gene editing platform, with BaseCamp, our end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.
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.
