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Senior Consultant CMC

Description of activities

  • Responsible for the management of all CMC technical development activities from pilot scale, process development to commercial scale for BLA/MAA and lifecycle management of marketed products for chemical, biological and blood-derived products
  • Prepare or review of CMC Sections of Regulatory Submissions
  • Review and approval of SOPs for analytical and manufacturing procedures
  • Review of user requirement specifications for pharmaceutical facilities
  • Participate in on-site audits of (bio)pharmaceutical companies, including deviations and CAPAs evaluations
  • Responsible for the review of CMC comparability for biosimilars

Education, experience and competences

  • PhD in Biotechnology and/or PhD in chemistry
  • 15 years plus experience of CMC development activities for producing clinical and/or commercial biopharmaceuticals are required
  • 10 years plus experience of CMC development activities for producing clinical and/or commercial chemical medicinal products
  • Familiarity with regulatory guidance pertaining to the Chemistry, Manufacturing and Control of manufacture of biologics chemical medicinal products is required
  • Extensive knowledge of GMP and practical know-how to work and manage within a regulated environment in biological/chemistry manufacturing is required
  • Excellent leadership skills with the ability to collaborate in a team
  • Effective verbal and written communication skills with technical writing skills are required.
  • Fluency in English and French