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Analytical Sciences Lead
4 weken geleden
As an Analytical Sciences Lead at Santen, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products. This position requires a strong understanding of analytical testing procedures, method development, and validation.
Key Responsibilities:- Provide expert support for analytical test methods, ensuring timely product release and continuous improvement of product quality and analytical procedures.
- Lead the execution of analytical method qualifications and validations, re-validations, and Annual Monitoring Batch (AMB) projects, collaborating with internal and external teams to ensure accurate execution.
- Develop and implement technical improvements to analytical methods, supporting method development for additional product and process-related characterization studies.
- Drive the qualification and/or validation of primary packaging materials testing methods, including container suitability studies.
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Technology, Chemistry, Engineering, or a related field.
- Minimum 5 years' experience as a QC/IPC laboratory scientist in a GMP environment or analytical methods development scientist.
- Familiarity with current CPV/OPV product and process data analysis and monitoring tools.
- Understanding of international regulatory requirements across multiple health authorities.
- Practical knowledge of standard pharmaceutical analytical testing and methods development.
Santen offers a competitive salary of $120,000 - $150,000 per year, depending on experience. Additionally, you will have opportunities for professional growth and development, flexible working arrangements, and a comprehensive benefits package.
