Senior Scientist, Upstream Viral Process Development

The role:

Reporting to the Director, Upstream Process Development, the Senior Scientist will contribute to upstream viral process development to bring the company’s pipeline of T cell and viral vector-based products to the clinic. Responsibilities will include, but are not limited to, performing the day-to-day activities of the viral process development lab, building the company’s viral manufacturing capabilities, and executing experiments to support viral process development/characterization. This role will collaborate significantly with research and analytical development teams, as well as contract development and manufacturing organizations.

Key responsibilities:

• Contribute to the setup and organization of the company’s vector process development capabilities.
• Develop bench scale suspension culture processes for viral vector generation within shake flasks and bioreactors through design and execution of experiments to support process characterization, and process transfer activities between the research team, TechOps, and external partners.
• Provide experimental execution, data review and analysis, and maintenance of accurate and detailed lab notebooks.
• Perform day-to-day activities in the vector process development lab including maintaining equipment, ordering materials and managing inventory, and preparing buffers and process aids.
• Author and review technical documents, including but not limited to batch records, SOPs, development reports and process-specific sections of regulatory documents.
• Represent the company externally at meetings (professional associations, with regulatory bodies, etc.).
• Serve as a PD subject matter expert on both internal and external teams (CDMO, material & equipment suppliers, etc.).

Required experience & skills:  

• Bachelor’s Degree in Chemical Engineering, Biochemical Engineering/Bioengineering, Biotechnology or related discipline with at least 10 years of relevant experience -OR- Master's Degree with 8 years -OR- PhD with 5 years
• Hands-on experience with viral vector upstream processing, including excellent small-scale aseptic technique and expert understanding of bioreactor operation and control loops
• Experience implementing processes in clinical and commercial manufacturing of cell and gene therapy/biopharma products
• Demonstrated ability to apply knowledge of cell biology, chemical engineering or bioengineering toward process development, scale-up/scale-down and troubleshooting
• Strong scientific reasoning, problem-solving, and applied mathematics and statistics skills, including the ability to break down complex problems into manageable hypotheses
• Proven experience collaborating with internal and external partners
• Ability to balance individual contributions while training and informally mentoring junior colleagues
• Working knowledge of GMP guidelines for clinical and commercial manufacturing
• Proficiency in using Microsoft Word, Excel, Power Point and data analysis/presentation software such as JMP and/or GraphPad
• Excellent interpersonal, verbal and written communication skills
• Strong organizational & problem-solving skills, with excellent attention to detail and the proven ability to collaborate in a dynamic team environment

Preferred experience & skills:

• Hands-on plasmid manufacturing experience or oversight of external plasmid manufacturing partners
• End-to-end experience in Lentivirus and Adenovirus development and manufacturing
• High-throughput bioreactors systems
• Drafting CMC sections for INDs
• Use of Artificial Intelligence (AI) to develop efficiencies and assist in tackling complex problems