Title: Scientist, Cellular Process Development
Location: Waltham, MA
Reports to: Principal Scientist, Cellular Process Development
ElevateBio is looking for a Scientist of Cellular Process Development. The Scientist of Cellular Process Development is responsible for designing and executing studies to translate innovative research and development program to GMP manufacturing. ElevateBio is looking for an innovative Scientist that can develop processes for genetically modified and minimally manipulated allogeneic and autologous cellular products. This Scientist will also play a crucial role in supporting current and future GMP manufacturing. The successful candidate must have successfully demonstrated technical proficiency, scientific innovation, independent thinking, and cross-functional collaboration in development of CAR/TCR T cell therapies.
Here's What You'll Do
+ Design and oversee cellular process development studies to translate research processes to those that are cGMP compliant
+ Work collaboratively with colleagues in ElevateBio’ s therapeutic development areas in a fast-paced environment for novel platform technology and therapeutic development
+ Identifies potential root causes using a systematic approach. Expertise in use / application of variety of problem-solving tools (e.g. Fishbone, Kepner-Tregoe etc.)
+ Act as the key member of both internal and external technology transfer activities
+ Design and conduct process characterization studies for cellular products
+ Represent process development functions in cross-functional team forums
+ Provide technical information to support process transfer document to support GMP manufacturing activities
+ Hire and manage key talent and provide strategic leadership to junior staff
+ Contribute to scientific publications and CMC regulatory submissions, as required
+ Degree in a biological science and relevant experience in T-cell immunology and biologics development including cell therapy development, immunology: PhD with 1-3 years of relevant experience; or a MS with 8-10 years of industrial experience, or BS with 10+ years of industrial experience
+ Extensive knowledge of T cell biology, large scale cell culture platforms, cell processing, and cell cryopreservation principles
+ Possess advanced skills in experimental design (e.g. DOE), data analysis and presentation
+ Experience authoring scientific publications and CMC regulatory submissions
+ Awareness of closed system processing, blood and cell processing technologies, cell characterization methods, manufacturing under cGMP, validation, and process comparability in a regulated environment
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.
Our Vision: 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.
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