- We are seeking a results-oriented, self-starter who demonstrates personal accountability for outcomes and thrives on increasing levels of responsibility, to join a new and dynamic team responsible for successful development and characterization of clinical-scale manufacturing processes for Chimeric Antigen Receptor T cell (CART) therapies.
- The successful candidate will help to develop and qualify analytical methods for the characterization, release and stability testing of CART products. In particular, this position will be responsible for the generation, integration, analysis, and interpretation of multi-parametric flow cytometry data, and from associated technologies, using bulk- and single-cell technologies.
- He/ she will collaborate with team members and key stakeholders, including the CART Process and R&D groups.
- Provide analytical support for clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including qualification of in-process and release methods, and tech transfer internally and externally, in support of manufacturing and release of clinical material. Actively contribute to successful development, qualification and execution of robust, state-of-the-art analytical methods for characterization of CART manufacturing processes and products.
- Collaborate productively to understand process/ product relationships, enhance product characterization, and help identify critical cellular quality attributes.
- Establish strong personal accountability, demonstrate good interpersonal skills, communicate and collaborate effectively with leadership and peers to ensure productive interactions, and contribute to project technical teams to ensure effective integration at all levels. • Apply good organizational skills, and sound scientific and technical experience to establish high-quality lab practices in order to maintain consistent and accurate test data.
- Ensure timely documentation in electronic laboratory notebooks, and author/ contribute to technical reports related to regulatory filings/ responses as appropriate
- Regularly present data/ strategy to scientists and management, in internal and external venues, as well as publish in peer-reviewed journals, as appropriate.
Technical Skills:
- Extensive multicolor flow cytometry (FACS)
- Immunology and T cells knowledges.
- Cell biology capability – cryopreservation, cell culture, cytotoxicity, cytokine, proliferation
- Biomarker experience is a plus.
What is the minimum education experience required?:
- B.S. +3 years or M.S. + 2 years in cellular biology, biological sciences discipline is preferred preferably in cell-scale studies, along with demonstrated advanced analytical and troubleshooting skills.
- Industry laboratory experience in a variety of analytical methods for the characterization and GMP release of cell-based or gene-related therapies, especially flow cytometry-related immunophenotyping.
Applied skills in cell biology, particularly in primary T cell culture/expansion and immunologic characterization.