Process Scientist- CMC
Our emerging Boston Biotech client who is transforming cell therapies for patients with incurable cancers through the use of T cells against oncogenic driver mutations is looking to add a Process Scientist I/II to their to their CMC team. This individual will be an integral member of the Process Sciences team driving manufacturing technology platform development for autologous and allogeneic gene-edited TCR-T cell therapeutics against solid tumors. The candidate will be engaged in the design and development of cutting-edge manufacturing processes and procedures to deliver cell therapy pipeline. The individual will support technology assessments and implementation of novel cell processing and gene editing strategies. This position will interact with both internal and external stakeholders including CMC, Discovery, Analytical Development, and Translational Research as well as academic and biopharmaceutical partners, CG&T industry technology developers, and contract research organizations.
- Brings significant technical expertise in T-cell biology, molecular and immunological function, and cell bioprocessing to the team.
- Lead platform development, proof-of-concept studies, and early process characterization to establish cGMP-ready cell manufacturing processes.
- Author technical reports, SOPs, QC sampling plans and other key process documentation including regulatory sections and filings.
- Develop novel non-viral delivery solutions for multiplexed cell engineering in collaboration with research and technical operations.
- Work collaboratively within the CMC organization and cross-functionally across Discovery Biology teams to understand, develop, and serve as a technical expert for cell manufacturing processes.
- Perform routine characterization testing as needed to support in-process and drug product testing.
- Collect, analyze, interpret, and present complex experimental data to key stakeholders and senior leadership.
- Stays current with relevant publications, and pragmatically applies promising innovations and insights to address key development challenges.
- Mentors junior staff and provides scientific guidance, fostering a culture of support and collaboration.
- Maintain meticulous documentation of laboratory procedures and experiments.
Education and Experience:
- B.S. in Chemical Engineering, Bioengineering, Biomedical Engineering, Biology, Immunology, or related discipline with 4+ years of relevant experience, M.S. with 3+ years of relevant experience, or PhD with 0+ years of experience.
- Extensive hands-on experience with state-of-the-art commercial cell processing devices and cell manufacturing unit operations including but not limited to immune cell isolation, T-cell activation, cell engineering, culture expansion, and formulation/cryopreservation.
- Experience in genetic modification of human primary cells and cell lines using gene-editing and viral/non-viral delivery technologies (LV, AAV, electroporation, LNPs, etc.)
- Proficiency in multi-parameter flow cytometry, panel design, and data analysis for phenotypic characterization of T-cells.
- Experience in execution and interpretation of T-cell functional assays including cytotoxicity, cytokine secretion, and proliferation is a plus.
- Possess knowledge of Quality by Design (QbD) principles, design of experiments (DOE) methodologies, cGMP requirements, and appropriate statistical analyses for Process Development.
- Excellent communication skills, both verbal and written, and the ability to interface effectively with cross-functional teams.