Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category:Scientific/Technology
All Job Posting Locations:Spring House, Pennsylvania, United States of America
Job Description:We are searching for the best talent for a
Senior Scientist, Downstream Process Development to be in Spring House, PA.
Purpose:The Senior Scientist, Downstream Process Development will lead development, optimization, and characterization of scalable purification processes for Lentiviral In-vivo therapeutic modalities, including biologics, and next-generation genetic medicines. This role will provide scientific leadership from early-stage development through clinical-stage readiness, with focus on purification platform strategy, process robustness, scale-up, and implementation of advanced downstream technologies.
You will be responsible for:- Lead development and optimization of downstream purification processes for lentiviral in vivo LV therapeutic products.
- Design and oversee chromatography, filtration, UF/DF, and formulation studies to improve product quality, yield, robustness, and manufacturability.
- Utilize advanced filtration technologies, including Ambr4 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.
- Evaluate emerging purification technologies and drive continuous improvement to enhance process robustness and development efficiency.
- 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.
Qualifications: Required:- PhD in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, or related field with 1-3 years of relevant industry experience; OR a 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 Ambr4 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.
Preferred:- Experience with high-throughput purification screening, Ambr4 TFF workflows, and 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.
Required Skills: Preferred Skills:Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy
