Stabilities and Samples Manager 5657 -LBD
Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalized Healthcare. As the world`s largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. A leader in the field of both in vitro diagnostics and manufacturing and selling of several innovative drugs.
We are currently looking for an enthusiastic Stabilities and Samples Manager , offering an initial contract of 12 months with high chances of extension to an open ended / unlimited contract to be based in Basel.
At the Basel Site, the area Synthetic Molecules Technical Development (PTDC) is responsible for late stage technical development of our Synthetic Molecules pipeline of Drug Substances (DS) and Drug Products (DP) for clinical trials.
Laboratory Support and Compliance provides key support activities for the analytical laboratories as well as to many internal and external partners who contribute to the development of Synthetic Molecules. Our main activities cover the qualification and maintenance of laboratory devices, stabilities and samples management, as well as activities related to the LIMS system.
- Ensure the Compliance of the work area
- Regular SOPs review and update
- Ownership of planned and unplanned events (PE resp. UPE in Veeva)
- Representative of the section in collaboration’s meetings at the local as well as at the global level, e.g., delivering a strong expertise and support during new projects and implementation of new systems
- Contribution to further implementation of the Single LIMS system
- Continuous improvement initiatives are required (identify opportunities pro-actively, take ownership implement harmonized/simplifying solutions)
- Support the Team in the operational level for stabilities studies and Samples Management:
- Set up, management and documentation of stability studies for NBEs (New Biological Entities) and NCEs (New Chemical Entities) in accordance with applicable regulations.
- Storage and retrieval of the stability samples using electronic tools and data
- Carrying out and documenting experiments to determine stability, e.g. stress, transport, in use, bulk or sun tests
- Administration and documentation of reserve and retain samples for NBEs and NCEs in accordance with regulatory requirements
- Samples coordination and distribution/shipping in the internal/external analytical laboratories
- Collaboration with PTDC Teams and establishment of new workflows compliant with the new systems and business needs
- Providing Users-Training and Support to the PTDC Organisation
- Troubleshooting & System adaptation management
- Ensure the regular communication and networking with other Sites across the globe, enabling continuous improvement and harmonization
- Support of future Digital Transformation activities
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required
- Degree in a scientific field (e.g., Pharmacy, Chemistry, Biology)
- 3-4 years of experience after graduation
- Experience in quality / laboratory work
- Strong GMP-understanding, incl. Data Integrity
- Strong sense of priorities and urgency
- Digital skills, affinity for databases
- German and English fluent (written and spoken)
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.