Senior Scientist, Downstream Process Development
On-siteSpring House, Pennsylvania, United States
Job Summary
Lead development and optimization of scalable purification processes for lentiviral in-vivo therapeutic modalities, including biologics and genetic medicines, from early-stage through clinical readiness. Design and oversee chromatography, filtration, UF/DF, and formulation studies to improve product quality, yield, and manufacturability while utilizing advanced technologies like Ambr® TFF for high-throughput screening and scale-down modeling. Operate and troubleshoot downstream equipment including AKTA systems and chromatography skids, applying Process Analytical Technology and digital bioprocessing tools to strengthen process understanding. Use JMP, MiniTab, or Python for multivariate data analysis and technical decision-making, while mentoring junior scientists and preparing regulatory documentation. Collaborate closely with analytical, formulation, upstream, and translational sciences teams to drive continuous improvement and platform development.
Required Qualifications
- PhD in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, or related field
- 1-3 years of relevant industry experience
- BS or MS with 4-6 years of relevant experience
- Extensive experience in downstream process development for biologics, cell therapy, gene therapy, or related viral vector modalities
- Hands-on experience with chromatography, clarification, depth filtration, UF/DF, sterile filtration, and process scale-up
- Experience operating and/or leading studies using AKTA chromatography systems, TFF platforms, and Ambr TFF systems
- Strong understanding of downstream process control strategies, process analytics, and process characterization principles
- Demonstrated ability to independently design, execute, interpret, and communicate complex studies
- Proven scientific leadership, mentoring, and project management experience
Desired Qualifications
- Experience with high-throughput purification screening
- Ambr TFF workflows
- Scale-down model qualification
- Familiarity with PAT tools, automation, digital bioprocessing, and advanced data analytics platforms
- Track record of scientific publications, presentations, patents, technology innovation, or cross-functional platform impact
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