CART Scientist

Job Description: Actively contribute to development, implementation, characterization and successful execution of robust, state-of-the-art CART manufacturing processes. Support clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including Tech Transfer to CMO and support of successful GMP manufacturing of clinical material. Contribute to relevant and impactful innovation programs to enhance CART manufacturing technologies/ capabilities and work-processes (such as alternate transfection/ cell engineering strategies, media development, disposable/ closed production systems and automation), aligned with emerging business drivers and Regulatory expectations. Contribute to Project Technical Teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups. Demonstrate strong personal leadership / accountability and technical and interpersonal skills, and apply scientific and technical experience to ensure safe, high-quality lab practices Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate. Present data/ strategy to scientists (and management) in internal venues (technical meetings, Project Team meetings) as appropriate.

Qualifications: Process development for GMP manufacturing of cell- or gene-therapies based on single-use bioprocessing technologies such as WAVE bioreactor, continuous centrifugation and CliniMACS cell separation. Culture and characterization of primary T cells, T cell molecular biology/ engineering, direct experience in T cell activation/expansion/selection, viral transduction and mRMA electroporation is highly desirable. Molecular virology/ engineering and / or production and purification of recombinant viruses such as lentiviral vector and AVV production based on transient transfection (CaPO4, PEI or electroporation).Familiarity with cGMPs and relevant Regulatory Guidance documents a plus

Additional Information: Best Regards, Anuj Mehta973-967-3402

Type: Contract

Function: Research

Experience level: Mid-Senior Level

Industry: Pharmaceuticals