GMP Bioconjugation Scientist - Abzena

GMP Bioconjugation Scientist

Location: Bristol, PA
Area: Chemistry

Main responsibilities

  • Perform and execute scale-up activities for GMP bioconjugation processes, including familiarization, optimization and trial runs. Bioconjugation processes include but not limited to the areas of ADCs, Fluorescent-Probe Bioconjugation and Protein-Protein cross-linking
  • Prioritize work assignments, consistently follow SOPs, Batch Records, ICH and FDA guidelines
  • Be responsible for the planning, development and optimization of synthetic routes/strategies, the execution and delivery of bioorganic reactions. This will include the preparation, purification and analytical characterization of all materials.
  • Perform laboratory scale experiments in support of GMP bioconjugation projects
  • Coordinate activities with QA, QC, Management, and other cross-disciplinary teams
  • Maintain clear and detailed records of their work in lab notebooks and batch records
  • Author SOPs, batch records and other relevant documents as necessary
  • Maintain a safe, pleasant and efficient working environment

Other responsibilities

  • Work with GMP Analytical for outline analytical methods needed to support GMP bioconjugation processes.
  • Act as the representative between R&D and the Quality Group for authoring and approving batch records for GMP bioconjugation processes.

Person Specification Essential:

  • B.S. or higher degree in biochemistry, biochemical engineering or related disciplines
  • 3-5 years of GMP operations experience
  • Experience in scale-up, Process Development and technology transfer of biologics downstream processes, including ultrafiltration/diafiltration and column chromatography methods
  • Ability to consistently work with stringent safety habits
  • Must be driven and motivated to work in a group or work independently

Desirable:

  • Experience in scale-up, Process Development and technology transfer of bioconjugation processes
  • Extensive knowledge of bioconjugation reactions and technical abilities to perform them
  • Ability to prepare, review and execute GMP documents (Batch Records, SOPs)
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