Senior Scientist, Cell Therapy Process Development

Responsibilities:

• Design and perform experiments to optimize integrated processes for cell therapy, including: evaluation of cell sources, isolation and activation of human immune cells, media optimization, viral/non-viral genetic modification, cell expansion, cell harvest/fill/finish, and cryopreservation.
• Cell therapy process scaleup, including: transition from open processes to closed automated systems, understanding analytical methods, using a Design of Experiments (DoE) approach, and evaluating process choices within a Quality by Design (QbD) framework
• Exploration of new technologies or materials for process scale-up or improvements with quality mindset leading to clinical or commercial readiness.
• Cross-functional collaborations in project teams to translate scientific understanding to development of phase appropriate cGMP cell therapy manufacturing unit operations.
• Lead the design, execution, and analysis of experimental studies for new manufacturing technologies and processes
• Author and review study protocols, technical reports, ELNs, regulatory submissions.
• Support authoring of key documentation to enable technology transfer (e.g. sampling plans, batch records, specifications, SOPs, FMEA, flow diagrams, etc.).
• Help coordinate sample management workflow across Process and Analytical Development teams and manage development database
• Serve as a technical resource/SME for GMP operations (e.g. root cause analyses and continuous improvement initiatives)
• Coordinate and prioritize tasks across multiple projects
• Maintain familiarity with current state-of-the-art related to cell therapy processes

Qualifications:

• BS/MS with 6+ years or PhD with 4+ years of experience in science/engineering of biopharmaceutical or cell/gene therapy process development and technology transfer
• Hands-on experience with automated cell processing units or platforms (i.e. bioreactors, automated cell wash, fill and finish) is critical.
• Experience developing and optimizing cell therapy processes for GMP production with quality mindset
• Strong technical writing and communication skills to support both development and tech transfer applications
• Strong critical thinking, organizational skills, ability to work in multi-functional project teams, and attention to detail
• Experience with various types of cell therapy products (i.e. CAR-T, CAR-NK, HSC, MSC) is preferred
• Experience with AI solutions for CGT processes and working with LIMS is a plus