Senior Scientist, Viral Upstream Process Development (Philadelphia, PA)
- Contribute to the setup and organization of the Client'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 Client 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.).
- Bachelor’s Degree with 10 years, Master’s Degree with 8 years or Ph.D. with 5 years in chemical engineering, biochemical engineering/bioengineering, biotechnology or related discipline
- 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
- End-to-end experience in plasmid and Lentivirus development and manufacturing
- Experience with high-throughput bioreactors systems, namely AMBR, but others will be considered
- Experience drafting CMC sections for INDs
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