SENIOR CONSULTANT CMC (H/F)

SENIOR CONSULTANT CMC (H/F)
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

Localisation

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