Bioanalytical R&D Resume of 10+years experience Resume
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Resume:
VISA, EMEA, WHO and CANADA under GLP environment.
Ø Develops and validates new LC-MS/MS methods for the quantitation of drugs and their metabolites in biological samples.
Ø Handling, Trouble Shoot & Calibration of Sophisticated Instruments.
Ø Manages Sample inventory and Storage.
Ø Prepares documents for Quality Control and Quality Assurance reviews.
Ø Prepares and updates SOPs to Support Regulatory Environment.
Ø Prepares Validation and Bioanalytical Reports.
Ø Preparation and updating of BE Study Summary Report.
Ø Preparation of Training materials and Conduct of in-house Training.
Ø Review of BE Protocols according to Regulatory Guidance (EU, US, WHO & Canada).
Ø Review of Chromatograms, Winnolinn data preparation,
Ø Review of Complete Analytical Results.
Ø Evaluation of Pilot study results for the initiation of Pivotal study.
Ø Final Report Review.
Ø Preparation of Standard Operating Procedures and Checklists.
Ø Compilation of Regulatory Queries and Response.
Other Technical Skills
Ø Performs routine maintenance of laboratory instruments.
Ø Serves as System Administrator for laboratory instrumentations.
Ø Identifies and maintains laboratory supplies.
LCMS/MS : Series-, , , of API SCIEX and TQMS
HPLC : Agilent-,, Series.UHPLC, Shimadzu,
Software : Analyst.., .., Chemstation, SDMS, NugenesisWinNonlin.
