Biotech Process Expert, Associate Principal Scientist

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