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We are seeking a highly motivated, 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 contribute to the development, implementation and characterization of state-of-the-art processing technologies to deliver scalable and robust manufacturing processes, and support successful tech transfer for GMP manufacturing and release at a CMO. This position will also contribute to the development of Client technologies and approaches to meet future CART manufacturing needs and will work in close collaboration with key stakeholders including the CART Research and Bioprocess R&D groups.
• 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
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