Beschreibung
Stabilities and Samples Manager (f/m/d) - Laboratory / GMP / LIMS / German / EnglishProject:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Stabilities and Samples Manager (f/m/d).
Background:
At Roche, we believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives. We are courageous in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
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.
The Department Operations Support & Compliance (OSC) is in charge of supporting all GMP and non-GMP relevant activities, and enabling the development of synthetic pharöaceutical molecules by providing high quality- and GMP- services to our partners.
Within OSC, our section 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.
The perfect candidate:
You are graduated in a scientific field (e.g., Pharmacy, Chemistry, Biology…), ensuring compliance and driving improvements and harmonization, looking beyond organizational boundaries.
In addition, you have a strong affinity and interest in Compliance, Systems and data bases, combinated with a high understanding of business needs and customer-orientation.
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 ONE ROCHE Mindset, 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.
* Autonomy, continuous learning
* German and English fluent (written and spoken)
Reference Nr.: 923120TP
Role: Stabilities and Samples Manager (f/m/d)
Industrie:Pharma
Workplace:Basel
Pensum: 100%
Start: 01.02.2024
Duration: unlimited
Deadline: 08.01.2024
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: .
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.