Main tasks:
1. Support the analytical activities required for producing information and documentation suitable for clinical development up to Process Validation stage products with particular focus on method suitability assessment/validation/verification/transfer in accordance with GMP, ICH guidelines and the company's quality system.
2. Build up a strong scientific knowledge on physical and chemical technologies with particular focus on pharmacopeia requirements and global alignment.
3. Promote the technical innovation, scientific understanding and best practices
4. Design and perform experiments, interpretate results and review data for physical and chemical techniques to support method implementation/validation/verification/transfer.
5. Prepare validation/transfer protocols/ reports and procedures related to physical and chemical test methods. Collect and evaluate scientific data to take conclusions based on them.
6. Summarize and communicate high quality information to customers and team members
7. Provide troubleshooting and training support for analytical method and instruments
8. Collaborate in the optimization of laboratory processes and corrective measures
9. Collaborate and lead laboratory investigations, Change request and CAPA implementation
10. Serves as Subject Matter Expert for the physical and chemical techniques
11. Coordinate projects tasks correlated to Analytical science team
What you bring:
12. Pharma industry /GMP/ transfer and validation experience 5+ years of experience
13. Bachelor's in relevant Field and Masters preferred
14. Business Fluent English, German is a plus
15. Excellent soft skills (Flexibility, critial thinking, customer service, communication
16. Tools knowledge: LIMS, Trackwise, DMS