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 next-generation genetic medicines. Design and oversee chromatography, filtration, UF/DF, and formulation studies to improve product quality, yield, and manufacturability. Utilize advanced filtration technologies, including Ambr® TFF, for high-throughput process screening, optimization, and scale-down model development. Oversee operation and troubleshooting of downstream equipment, including AKTA systems, TFF systems, and chromatography skids. Apply Process Analytical Technology, online monitoring, and digital bioprocessing tools to strengthen downstream process understanding. Use JMP, MiniTab, Python, Spotfire, or similar platforms for multivariate data analysis, process modeling, and technical decision-making. Lead process characterization, scale-up, and platform development activities to support clinical manufacturing readiness. Collaborate closely with analytical, formulation, upstream, modeling, automation, MSAT, and translational sciences teams. Mentor junior scientists and provide scientific leadership across programs and cross-functional workstreams. Prepare technical reports, development strategies, scientific presentations, and regulatory documentation.
Required Qualifications
- PhD in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, or related field
- 1-3 years of relevant industry experience
- BS or MS degree 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
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.