Main tasks:
* 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.
* Build up a strong scientific knowledge on physical and chemical technologies with particular focus on pharmacopeia requirements and global alignment.
* Promote the technical innovation, scientific understanding and best practices
* Design and perform experiments, interpretate results and review data for physical and chemical techniques to support method implementation/validation/verification/transfer.
* 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.
* Summarize and communicate highquality information to customers and team members
* Provide troubleshooting and training support for analytical method and instruments
* Collaborate in the optimization of laboratory processes and corrective measures
* Collaborate and lead laboratory investigations, Change request and CAPA implementation
* Serves as Subject Matter Expert for the physical and chemical techniques
* Coordinate projects tasks correlated to Analytical science team
What you bring:
* Pharma industry /GMP/ transfer and validation experience 5+ years of experience
* Bachelor's in relevant Field and Masters preferred
* Business Fluent English, German is a plus
* Excellent soft skills (Flexibility, critial thinking, customer service, communication
* Tools knowledge: LIMS, Trackwise, DMS
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