• 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.
Technical Skills Requirements:
BS or MS degree in Molecular Immunology/ Molecular Biology, Bioengineering, or related degree (with appropriate cell and gene therapy focus) with 3+ years (1+ for MS) of experience in biotech/biopharma industry (preferably in the development and characterization of manufacturing processes for cell- or gene-based therapies).
• Process development for GMP manufacturing of cell- or gene-therapies
• Culture and characterization of primary T-cells, T-cell molecular biology/ engineering
• Aseptic cell culture technique
• Direct experience with T-cell activation, viral transduction, and mRNA electroporation is highly desirable
• Familiarity with cGMP and relevant Regulatory Guidance documents a plus
• Familiarity with single-use bioprocessing such as WAVE bioreactors and CliniMACS Prodigy a plus
• Experience with process scale-up and scale-down is desired
• Knowledge with Design of Experiments a plus