Descripción del Empleo:
Supports the technical in-process, release, and stability methods for bulk and/or drug products.
2. Performs troubleshooting to solve analytical-related problems during in-process, release, and stability testing to determine remedial steps to correctly resume testing, while guaranteeing compliance.
3. Serves as a liaison between Quality Control and other support groups (e.g. QA, Validation, and Analytical Research) to assure that current laboratory method issues are being properly addressed.
4. Designs, evaluates, and executes Analytical Method Transfer protocols.
5. Executes transfer and start up of new and existing methods into the Quality Control ensuring that critical assay parameters are clearly communicated to the receiving site.
BS Degree in Natural Science in Biochemistry or Chemistry.
• The experienced required based on Degree is:
? BS Degree with five (5) years experience in pharmaceutical industry with at least two (2) years experience in method development/transfer of biomolecules.
? Master Degree with at least (2) two years experience in pharmaceutical industry in method development/transfer of
? PhD Degree with experience in handling, analysis, and method development of biomolecules.
• Technical knowledge of proteins handling and analysis with specific experience in biomolecules method optimization and troubleshooting.
• Broad experience with analytical instrumentation and techniques (e.g. HPLC, GC, UV, FTIR, MS, CE, SDS-PAGE, SEC, ELISA)
• Literacy of pharmaceutical industry analysis of Bulk Products and/or finished dosage forms.
• Computer literacy (Microsoft office, etc)
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