Analytical Science & Technology Expert
Our client is a leading global layer in the Pharmaceutical industry with global headquarters in Basel Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focuses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world. We are currently looking for an Analytical Science & Technology Expert.
- Implement and support global AS&T programs in External Supply.
- Defines and implements the business processes and SOPs necessary to maintain a robust Quality System within External Supply affecting the laboratory activities (e.g. management of changes, maintenance of testing monographs)
- Support Implementation of Guidelines at external partners and suppliers
- Lead programs and initiatives to implement changes and to remediate where required
- Interprets stability data, analyses trends, and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories. Provide corrective actions to address immerging stability issues.
- Support external suppliers qualification process
- Support Tech Transfer assessments for analytical method transfers.
- Lead QC aspects of Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
- Support assessments of analytical Change Control records for acceptability. Define studies needed to support the changes.
- Interacts with the External Supplier to guarantee suspect analytical results investigations are managed in agreement with standards and the right CAPA is implemented.
- Ensure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation. Support programs and initiatives to implement changes to, and upgrade Testing Monographs where required
- Support site readiness for Health Authority inspections & participate in audits on request.
- Escalate any issues or instances of instability per the escalation policy, and initiate any market action that is required.
- Support analytical trouble shooting as needed.
Qualifications and Experience:
- University or academic degree in Chemistry, Biology, Pharmacy or equivalent
- Deep knowledge of analytical method development for APIs (HPLC; UPLC, GC, UV-Vis, IR)
- Strong expertise in ICH guidelines for Validation and Transfer of those methods
- Good IT skills, ideally in SAP
- GMP experience
- Fluent in both written and spoken English, German desirable
- Relevant working/residency permit or Swiss/EU-Citizenship required