Upstream Process Development Scientist

3 weeks ago

Houston, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Science & Clinical is currently seeking an Upstream Process Development Scientist for a biopharma/biotech company in near Southwest Houston. The Upstream PD Scientist will focus on will focus on the planning, execution, and analysis of studies targeted to support the client’s viral vector platform. The role will center on producing recombinant AAV vector preparations in for preclinical studies, toxicology batches, reference material, and clinical products. Job functions will include routine cell expansion, cell screening, production of viral vector(s), small and pre-clinical material generation in large scale bioreactors, and filtration.


Responsibilities

  • Independently perform routine suspension cell culture (sampling, cell counting, passaging)
  • Independently maintains and manages upstream equipment appropriately
  • Support upstream technology strategies in various platforms including shakes flasks, rocker, 2L, 3L, 10L, and 50L from the development stage, tech transfer, engineering runs, and GMP manufacturing ; Assist in and execute unit operations for development, toxicology, and GMP batches for viral vector production(s).
  • Contributes to continuous improvement strategies by designing experiments and presentation of results to internal and external stakeholders; evaluation of new technologies and collaboration with vendors
  • Independent execution in the preparation of buffers/reagents ,bioreactor set-up (bench-top to 50L SUB), and sampling operations, monitoring of process performance, as well as cleaning and waste disposal to support process development operations.
  • Ensuring adequate and appropriate inventory of materials and supplies, collaboration with supply chain, ordering materials
  • Draft, edit, and/or review data capture forms, batch production records, standard operating procedures or standard work elements for process development equipment and/or unit operations.
  • Maintain responsible laboratory protocols, data capture, lab notebooks, and/or files using GDP
  • Collaborates with pre-clinical, analytical development, quality control, and manufacturing on the planning of upstream process development project timelines


Education and Experience

  • BSc in a Biological Science/ Chemistry/ Chemical Engineering
  • 3-5 years of experience in AAV gene therapy
  • Experience in and understanding of operations within a biosafety cabinet, cell culture incubators, cell culture shaking platforms, centrifugation equipment, aseptic technique, and associated general cleaning procedures
  • Experience with media preparations, monitoring cell culture, routine sampling, preparation, execution, and analysis of cell expansion
  • Handling various sized shake flasks and small-scale bioreactors in a process development setting
  • Large-scale bioreactor experience is a plus
  • AAV bioprocessing and development is a plus
  • Experience with cell line development is a plus
  • Experience in a GMP environment is a plus

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