Our jobs
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
