Title: Sr. Scientist, Cellular Process Development
Location: Waltham, MA
Reports to: Associate Director, Cellular Process Development
The individual will be a key contributor to the process characterization of late-stage cell therapy manufacturing processes. He/she will design, perform, and interpret complex experiments in collaboration with other process development scientists. He/She will have an extensive understanding of cell biology and Immunology with direct experience in the development and characterization of cell and gene therapies. The Sr. Scientist will work collaboratively in a cross-functional manner and provide guidance for experimental design to further understanding of processes and impacts to drug product attributes.
- The individual will be a laboratory leader responsible for both the design and execution of complex small-scale and commercial-scale experiments following a Quality by Design (QbD) approach
- Execute and document risk assessments to identify critical quality attributes (CQA)
- Support cross-functional efforts to develop a process control strategy including classification of critical process parameters that impact CQAs as well as the strategies for appropriate control of CQAs
- Generate Process Justification and Control Strategy documents
- Review and approve PVMP, PPQ protocols and reports
- Author process validation documents and technical reports detailing experimental work, and summarizing outcomes
- Author CMC regulatory submissions and contribute to scientific publications, as required
- Manage at least one junior scientist potentially across multiple projects involving both genetically modified and non-genetically modified T cell therapies
- Define/maintain a safe work environment in accordance with policies/procedures/regulations
- Represent process development functions in cross-functional team forums
- Work collaboratively with colleagues in ElevateBio’s portfolio companies
- Degree in a biological science and relevant experience with T cell therapies; PhD with 1-3 years of post doc; or a MS with 8-10 years of industrial experience, or BS with 10+ years of industrial experience
- Familiarity with Process Validation guidelines (ICH, PDA)
- Experience with quality risk assessment tools
- Possess advanced skills in experimental design (e.g. DOE), data analysis and presentation
- Familiarity with a Quality by Design (QbD) approach to process characterization activities as well as product lifecycle management
- Experience authoring scientific publications and CMC regulatory submissions
- Experience with advanced closed system processing methods, blood and cell processing technologies, cell characterization methods, manufacturing under cGMP is highly desired but not required
- Demonstrated leadership and critical thinking skills and ability to effectively motivate and manage a team of scientists in a fast pace work environment.
- Direct experience with T cell culture and techniques to characterize T cells including phenotype, cytokine analysis, cytotoxicity, and proliferation assays is required
- Understanding of safe lab practices and BSL requirements
- Detail-oriented, organized, and technically competent Interpersonal and leadership skills to work with teams in different functions and organizations
- Strong engineering or scientific knowledge appropriate for cellular process development
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. ElevateBio is also a leader in corporate philanthropy and has taken a pledge to donate a portion of product sales to fund promising cancer research and to support cancer care in the developing world.
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.
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Posting ID: 569602872Posted: 2021-01-15