- Analytical R&D will support R&D and work with QA and Operations by developing, validating and transferring analytical methods and analyzing raw materials and products (in-process and finished)
- Design and carry out experiments to solve technical problems
- Carry out forced degradation study and identify impurities/degradation products
- Develop and optimize analytical methods for testing of drug substance and products; conduct validations appropriate to the stage of the project to support R&D efforts
- Test drug products and/or drug substance/raw materials
- Write protocols and reports
- Work in compliance with all US (e.g., FDA Guidelines, cGMP) and international regulatory agencies (e.g. ICH Guidelines, EMEA Guidelines) and compliance requirements (cGMP and Quality System) as they relate to analytical testing and drug formulation
- Ph.D. in Chemistry with 5 years of experience in pharmaceutical development or drug delivery, or equivalent combination of education and experience, familiar with GxP and ICH Guidelines
- The candidate should have advanced computer skills specifically in Microsoft Word, Excel and good written and verbal communication/presentation skills
- Expertise on LC/MS, HPLC, method development, GC, GC/MS
- Working experience on Millenium/Empower
- Experience on dissolution and physical testing is a plus
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