Scientist - Downstream Process Development at Kelly

Kelly Government Solutions is seeking a Scientist – Downstream Process Development to work on-site with the Vaccine Production Program at the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) in Gaithersburg, MD. KEY TASKS/SERVICES(1) Support the Purification group of the Vaccine Production Program (VPP) Labs of the Vaccine Research Center (VRC).(2) Develop downstream (purification) processes, under the supervision of a project lead scientist, for recombinant proteins, virus vaccines, and virus-like particles (VLP) that may be used as clinical vaccine candidates.(3) Serve as a functional lead in chromatography process development unit operations.(4) Provide critical process step assessment and experimental design to define optimal process parameters for chromatography unit operations.(5) Train team members in large-scale unit operation such as AxiChrom column packing and Pilot-scale chromatography execution.(6) Work independently and collaboratively within the purification group to design, develop and optimize chromatography and filtration step unit operations to support process development of clinical trial vaccine candidates and mAb products.(7) Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles in support of other groups at the VRC.(8) Work to prepare necessary materials (buffers, packed columns, etc.) in support of downstream process activities.(9) Perform protein/small molecule conjugation experiments to support method development or conjugate-based vaccine candidates.(10) Support technology transfer of processes to VRC Pilot Plant for manufacture of clinical products including authoring process descriptions, reports, and on-floor support.(11) Author training documents, process documents and summaries, instrument SOPs, technical reports, protocols, and other supporting documentation.KEY REQUIREMENTS(1) Ph.D. in a scientific field with at least 5 years of experience. MS with at least 10 years of specialized experience may also be considered.(2) Deep understanding of challenges and method development approaches of mAb, vaccine and mRNA scientific field.(3) Familiarity with monoclonal antibody and multi-specific antibodies, recombinant protein vaccine and nanoparticles; mRNA and mRNA/LNP vaccines.(4) Analytical skills and applications such as developing release and characterization methods using reversed phase HPLC/or UPLC -UV methods or HPLC/or UPLC – MS methods for pipeline project support.(5) Experience with other bio-separation techniques such as electrophoresis and lab-on-chip separation.