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A prominent biotechnology firm is seeking a skilled individual to join their team focused on CAR-T therapies. This role includes developing analytical methods, managing flow cytometry data, and collaborating with R&D groups to support clinical manufacturing processes. The ideal candidate will possess a deep knowledge of cellular biology, solid analytical skills, and hands-on experience in laboratory settings.
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 (CAR-T) therapies.
The successful candidate will help develop and qualify analytical methods for the characterization, release, and stability testing of CAR-T products. This position will be responsible for generating, integrating, analyzing, and interpreting multi-parametric flow cytometry data, along with associated technologies, using bulk- and single-cell technologies.
He/She will collaborate with team members and key stakeholders, including the CAR-T 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 technology transfer internally and externally, supporting the manufacturing and release of clinical material. Actively contribute to the development, qualification, and execution of robust, state-of-the-art analytical methods for the characterization of CAR-T manufacturing processes and products.
Collaborate to understand process/product relationships, enhance product characterization, and 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 teams to ensure effective integration at all levels. Apply good organizational skills and sound scientific and technical experience to maintain high-quality lab practices for consistent and accurate test data.
Ensure timely documentation in electronic laboratory notebooks and contribute to technical reports for regulatory filings and responses as appropriate.
Regularly present data and strategies to scientists and management in internal and external venues, and publish in peer-reviewed journals as appropriate.
Applied skills in cell biology, particularly primary T cell culture/expansion and immunologic characterization.
All your information will be kept confidential according to EEO guidelines.