Advisor, Downstream Process Development – Viral Vectors

Key Responsibilities

• Design and execute downstream process development experiments for AAV purification, including affinity capture, ion-exchange chromatography, ultrafiltration/diafiltration, viral filtration, and ultracentrifugation
• Develop and implement novel AAV purification strategies; establish DSP operating principles and process understanding across diverse serotypes
• Develop and apply mechanistic chromatography models to predict column performance, guide operating condition selection, and accelerate scale-up decisions, enabling rapid initiation of new gene therapy programs
• Collaborate cross-functionally with upstream process development, analytical development, manufacturing, and quality teams to ensure seamless technology transfer and successful clinical manufacturing
• Present experimental findings at internal team meetings, cross-functional reviews, and external conferences; contribute to scientific publications and patent applications as appropriate
• Author and review technical documents including process descriptions, batch records, process characterization reports, and CMC sections of IND/BLA filings
• Mentor junior scientists, fostering a culture of scientific excellence and continuous improvement

Basic Qualifications

• Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related scientific discipline with at least 2 years of relevant experience in downstream process development for biologics or gene therapy products, OR M.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related scientific discipline with at least 10 years of relevant industry experience
• Extensive hands-on experience with various protein purification techniques: chromatography (affinity, ion exchange, HIC) and membrane-based separations (UF/DF, depth filtration)
• Demonstrated fundamental understanding of chromatography principles
• Proficiency in statistical design of experiments (JMP, Minitab) and data analysis
• Excellent problem-solving skills, critical thinking, and ability to work independently and as part of a team
• Strong written and verbal communication skills with the ability to effectively present complex scientific information

Preferred Qualifications

• Experience with recombinant AAV or other viral vector purification (lentivirus, adenovirus)
• Experience with automation platforms for HTP process screening
• Proficiency in Python and/or MATLAB for data analysis, model implementation, and automation scripting
• Knowledge of machine learning / multivariate analysis applied to bioprocess data
• Strong understanding of viral vector biology, expression systems, and analytical methods used for viral vector characterization