(Associate) Scientist, Upstream Viral Process Development

The role:

Reporting to the Director, Upstream Process Development, the (Associate) 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.

Key responsibilities:

• Contribute to the setup and organization of the company’s vector process development capabilities.
• Perform day-to-day activities in the vector process development lab including maintaining equipment, ordering materials, managing inventory, and preparing buffers and process aids.
• Serve as a PD subject matter expert on both internal and external teams (CDMO, material & equipment suppliers, etc.).
• Develop bench scale suspension culture processes for viral vector generation within shake flasks and bioreactors.
• Design and execute 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.
• 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.)

Required experience & skills:

• Bachelor’s Degree in chemical engineering, biochemical engineering/bioengineering, biotechnology or related discipline with at least 2 years of relevant experience- OR- Master's Degree in relevant discipline
• Hands-on experience with viral vector upstream processes, particularly experimentation in and operation of stirred-tank bioreactors
• Working knowledge of GMP guidelines for clinical manufacturing
• Strong scientific reasoning, problem-solving, and applied mathematics and statistics skills, including the ability to break down complex problems into manageable hypotheses
• 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:

• Experience implementing processes in clinical and commercial manufacturing of cell and gene therapy products
• Demonstrated ability to apply knowledge of cell biology, chemical engineering, or bioengineering toward process development, scale-up /scale-down and troubleshooting
• Detailed understanding of bioreactor operation and control loops
• Experience drafting CMC sections for INDs
• Proven experience collaborating with internal and external partners