Job Details

  • Title: Associate Scientist
  • Code: RCI-08346
  • Location: Santa Monica California (CA) 90404
  • Posted Date: 05/18/2020
  • Duration: 12 Months
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  Job Description

This individual will be an integral member of the Upstream and/or Cell line development of the viral vector programs. The individual will contribute to the development, scale up and technology transfer of the viral vector production with focus on viral vector cell line and cell culture development. These activities can include molecular cloning (e.g. application of recombinant DNA technologies for construct generation and analysis), lead clone selection, aseptic cell culture of viral vector suspension and adherent cell lines, scale-down model development and qualification, process optimization, robustness studies, and process characterization. These roles and responsibilities will include molecular cloning (e.g. application of recombinant DNA technologies for construct generation and analysis), aseptic cell culture of viral vector cell lines, transfection and selection of mammalian cells, cell cloning, and evaluation of clonal cell lines in scale-down models of the production system.

  • Active member of the viral vector upstream team would design, plan and execute laboratory studies in order to support process development, characterization or process improvements
  • Perform hands on work in an adherent cell stack factories or suspension culture, cell culture expansion, viral vector production as well as process scale up and implementation into GMP clinical production suites
  • Write and review technical documentation
  • Participate and influence a cross-functional development team to advance production activities
  • Develop manufacturing processes for viral vector products and develop process improvements and efficiencies
  • Perform process analysis and trend process performance
  • Design and execute process development studies to develop a thorough understanding of operating and performance parameters
Required Skills:
  • Knowledge of suspension or adherent cell culture formats, scale-up and engineering principles (e.g. growth rates, specific consumption/production rates, bioreactor aspect ratios, power calculations, gas transfer, shear stress)
  • Hands on expertise in cell line engineering, attribute selection and cell sorting (FACS) is required with experience in isolating high productivity cell lines
  • Hands on expertise in laboratory cell culture operations such as maintenance and growth of cells in both static and suspension modes
  • Previous experience in the development of high productivity and suitable vector cell lines is required
  • Demonstrated excellence in viral vector or cell culture process development, process technology transfer, scale translation, and statistical DOE (design of experiments)
  • Build, operate, and troubleshoot bench top and pilot scale bioreactors; compile and analyze results
  • Excellent communication and presentation skills and aptitude for problem solving
  • Experience with the preparation of regulatory filings for US and external markets is desired
  • Candidate should be self-motivated, ambitious, organized, and collaborative
  • Understanding of GMP manufacturing
  • Act as an effective and committed team player
  • 7+ years of experience with BS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline OR 5+ years of experience with MS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline
  • Previous experience with Cell therapy products, viral vector production in both adherent and suspension cell culture systems, transient transfection and/or stable cell lines is desired
  • A previous track record of culture process development experience such as cell passaging, formulation of media, aseptic technique processing, and managing reagents
  • Practical demonstration of hands on process development including use of statistical design of experiments is required. Experience with automation technologies is desired
  • Practical experience of cGMP manufacturing operations and fluency of regulatory regulations is desired
  • Ability to think critically, and demonstrate troubleshooting and problem solving skills
  • Excellent interpersonal, verbal and written communication skills are essential
  • Self-motivated with a strong sense of ownership in areas of responsibility and willingness to accept temporary responsibilities outside of initial job description
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace and dynamic team setting
  • High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles