Duties:
Perform dose formulation analysis under FDA GLPs for nonclinical studies.
Provide dose formulation stability testing for GLP studies.
Develop and validated analytical methods for doser formulation analysis.
Assume responsibility for analytical support of nonclinical studies as contributing scientist/principal investigator working with BI nonclinical drug safety study directors and CRO scientists/study directors.
Review laboratory notebooks and chromatographic data.
Write analytical reports for inclusion in nonclinical study reports.
Write dose formulation stability reports for GLP study support.
Skills:
Expertise in HPLC and analytical method development. Preferred experience in GLPs, Microsoft Office, Empower chromatographic data system.
Education:
Bachelor’s Degree and 7-10 years’ experience in analytical chemistry/chromatography
Richha Saini
Senior Clinical/Pharmaceutical Recruiter
Tel: (201) 524 9600Ext 7179
Direct: 781-262-3067