Job offer from Thursday, May 16, 2019

Senior Consultant CMC

Triskel Integrated Services S.A.Le Grand Saconnex
  • Le Grand Saconnex
  • Small and medium-sized enterprises
  • Unlimited employment, 100%
  • Executive po­si­tion

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
  • Swiss or valid swiss working permit

Chemin du Pavillon, 5 1218 Le Grand Saconnex

1 job — Le Grand Saconnex

Salary Check

Take advantage of the jobs.ch service to find out how much you earn as Consultant.
This website uses cookies to ensure you receive the best service. Further information can be found in our Terms and Conditions and in the Privacy Policy.