Senior Scientist - Viral Clearance will participate on the Viral Clearance Technical Team to help plan viral clearance studies and to troubleshoot study design both before and after study execution. This role encompasses all virus removal steps (multiple types of chemical inactivation, viral retentive filtration and column chromatography) commonly employed in the purification of biologic pharmaceuticals.
You will also be a contributor to the process development, including optimization and characterization, scale-up and tech transfer to GLP virus production group, for all wild-type viruses to be used in viral clearance studies. Focus will be on the bench-scale laboratory development of purification unit operations such as cell culture clarification, column chromatography (affinity, ion exchange, SEC, etc.), ultrafiltration/diafiltration.
Work within a team environment to design and execute purification experiments and interpret data, and work with other team members to integrate results into process designs and overall project plans.
Optimize the virus purification and production process
Troubleshoot and potentially optimize existing testing methods
Provide guidance/assist in troubleshooting data analysis
Stay current with regulatory standards (viral safety, process validation, GxP, etc.).
Display a diligent and self-motivated approach to working in and/or running the laboratory.
M.S. in Chemical/Biochemical Engineering, Biochemistry, Chemistry, with 5+ years relevant industry experience, or B.S. degree with 8+ years of similar experience.
Must be an expert in purification and process development, with a demonstrated record of scientific achievement and a broad and integrated knowledge of the field.
Knowledge and practical understanding of viral clearance and experience with the AKTA Explorer or Avant systems is a must.
Must be able to manage efforts across multiple projects.
Excellent verbal and written communication skills and a demonstrated ability to work as part of a project team.
Candidate must be willing to work in a BSL-2 laboratory setting with wild-type mammalian viruses.