ElevateBio is a cell and gene therapy technology company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies.
The Associate of the Analytical Testing Core is responsible for performing non-GMP assays in support of the research and development functions at our Basecamp facility in Waltham. This position will work with Analytical Development to transfer pre-qualified assay into the Analytical Core for routine use. Once transferred, the associate will receive, prepare and test samples per the established test method. Upon testing completion, the associate will ensure the timely review and reporting of data to the submitting group.
Here’s What You’ll Do:
- Work with management to implement laboratory systems to manage sample receipt, test execution, data integrity and reporting
- Draft SOPs and test record for the processes and equipment used in the Analytical Testing Core
- Implement test methods developed and pre-qualified/qualified in Analytical Development for routine non-GMP testing
- Perform daily laboratory operations, including: routine testing, inventory management, reagent ordering and maintenance activities
- Communicate with management and cross-functional stakeholders to ensure all testing is initiated and completed within required project timelines
- Maintain metrics to evaluate and monitor the performance of the analytical core laboratory
- Bachelor’s degree with 1-3 years experience in a technical discipline (Biology/Chemistry/Microbiology or related field)
- Experience working in an Analytical Development or Quality Control setting preferred
- Experience with gene and cell therapy test methodologies (cell culture, PCR, Flow Cytometry, ELISA, HPLC, AUC, CE and cell-based assays)
- Ability to work in a collaborative team environment to meet project goals and testing turnaround times
- Strong communication skills with an ability to clearly present complex scientific concepts and data
- Experience in cell and gene therapy manufacturing environment is a plus
- Experience working with electronic systems (LIMS and ELN) is a plus
Why join ElevateBio?
ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities.
At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.
Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.