Research Associate II
400 Interstate North Pkwy, Suite 425 Atlanta, GA | Contract
• 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.
• Process development for manufacturing of cell or gene therapies
• Culture and characterization of primary T cells, T cell molecular biology/ engineering
• Molecular virology/ engineering and/ or production of recombinant viruses
• Familiarity with cGMPs and relevant Regulatory Guidance documents a plus
• Routine laboratory bench work involving prolonged standing and frequent walking
• Occasional weekend and after-hour work is expected
• Handling of biohazardous materials, including human blood samples (screened) and lentivirus is expected