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Stabilities and Samples Manager (f/m/d)

Other
Basel
English

For our client, an international pharmaceutical company based in Basel, we are looking for a Stabilities and Samples Manager (f/m/d).



General Information:

  • Start date: ASAP
  • Planned duration: unlimited
  • Workload: 100%
  • Remote/Home Office: predominantly onsite, single days of remote are possible (when only document work needs to be done)



Tasks & Responsibilities:

  • 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 SingleLIMS 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



Must Haves:

  • 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
  • Strong willingness to support colleagues within the section, and jump in lab support topics according to areas of expertise
  • Excellent coordination and Change management skills
  • Very high agility and flexibility
  • Digital skills, affinity for databases
  • High ability for relationship-building, collaboration as ONE-Team and Networking at the local level as well as at the Global level.
  • German and English fluent (written and spoken)