For our client, a pharmaceutical company based in Canton of Neuchatel, Kelly Life Sciences is looking for a:
- The Specialist Stability is responsible for handling the stability program for all commercial products internally and externally.
- Performing tracking and trending stability data results.
- Key Subject Matter Expert in commercial drug product and drug substances stability.
Commercial Stability program:
- Responsible for the handling of commercial stability program for Celgene products: scheduling, batch selection, setup, sampling, coordination, etc.….
- Responsible for the creation of stability protocol as well as Master Data management and the creation of stability study (e.g.LIMS system)
- Track and trend stability data for commercial products internally and externally
- Participate in external and internal audits
- Responsible for the global stability SOP / WP
- Responsible for the annual stability report
- Manages the master data for stability samples
- Support the management of global reference standards and control products
Support Commercial drug substances and drug product:
- Collaborates with QA on deviations
- Leads work activities involving Change Controls and CAPA's
- Represents department in cross functional projects
- S. Chemistry, Biology, Microbiology or relevant discipline
- 5 years of relevant work experience required, preferable in a pharmaceutical environment
- Advanced understanding of pharmaceutical regulatory requirements and their impact to commercial laboratory operations
- Advanced knowledge in stability protocol definition
- An equivalent combination of education and experience may substitute
- Advanced knowledge in English and French
Please apply online, Aymeric Shimamungu will be pleased to talk with you.