Biotech Process Expert, Associate Principal Scientist

Posted 1 year ago

Key responsibilities:

  • Coordinate outsourced activities, ensuring CDMOs accountability for the quality of their products and documentation as well as on-time delivery of the biotech APIs
  • Plan and coordinate team meetings with CDMOs and follow-on with actions
  • Review technical proposals from CDMOs
  • Review external documentation (protocols, reports, quotations, batch reports…)
  • Perform data analysis, data aggregation and reporting
  • Contribute to the preparation of CMC and regulatory documentation for biotech APIs
  • Ensure that external activities adhere to GMP, regulatory guidelines, standard processes and SOPs, where applicable
  • Propose process optimizations and recommend technologies in relation to bioprocessing
  • Assist with requests from Health Authorities
  • Keep aware of current scientific and regulatory knowledge as well as main actors in the field of biological products
  • Contribute to the development of internal expertise for bioconjugates

Your profile:

  • Engineering Degree (Biotechnology, Biology or Biochemistry)
  • Must have >7 years of experience in a Pharmaceutical or Biotech Manufacturing organizationin various stages of project development
  • Comprehensive understanding of the global development of biologicals from preclinical to late-stage clinical development
  • Direct experience in the manufacture of biotech products such as Antibodies and Antibody Drug Conjugates
  • Comprehensive understanding of CMC and regulatory aspects for biotech products
  • Knowledge of analytical requirements for biotech products
  • Expertise in working with sub-contractors and ability to coordinate external activities
  • Strong communication, team spirit and organizational skills
  • Direct management of cross-functional teams is a plus
  • English fluent spoken and written is mandatory

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