Bioanalytical R&D Resume of 10+years experience

Ø  Acts as Project Leader for Good Laboratory Practices (GLP) BA/BE Studies

Ø  Analyzes samples as per various Regulatory Guidelines such asUSFDA, ANVISA, 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-4000, 3200, 3000, 2000 of API SCIEX and TQMS

HPLC            : Agilent-1100,1200,1260 Series.UHPLC, Shimadzu,

Software       : Analyst1.4.1, 1.6.2, Chemstation, SDMS, NugenesisWinNonlin.