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 Mehta

973-967-3402