Senior Scientist, Antibody Upstream Processes Development

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Job Description:

We are looking for an experienced and motivated senior/principal scientist on antibody upstream process development.

 

Responsibilities

  • Responsible in the processes development of the antibody drug, such as cell line generation, antibody purification and process development, quantity control etc.
  • Initially work with third parties (CROs or CMOs), monitoring the key control points as well as milestones and report the progress, work closely with research team and provide technique support in the antibody developability evaluation and QC assay develop.
  • Work independently on stable cell line generation and/or antibody biophysics analysis.

 

Qualification

  • MS/PhD degree with more than 3 years’ experience in at least one of following area: stable production cell line (CHO) development, culture/expansion, purification, process development, pre-formulation/formulation analysis.
  • Familiarity with FDA, cFDA guidance about biological drug development and production, understanding of GMP antibody production process.
  • Hands-on experience with mammalian cell culture, aseptic techniques, understanding of biochemical engineering concepts, and biochemical pathways.
  • Excellent record keeping abilities to adequately document process development data.
  • Strong verbal and written communication skills and ability to communicate within the organization as well as externally.