Analytical Chemist

SANTHI PENGHAT

**** ********* ****, *** *

Cupertino, CA 95014

Phone: 408-***-****

Email: *************@*****.***

Objective:

Application for the position of Chemist III

Summary of Work experience

• Worked in GMP-Pharmaceutical R&D Laboratory for 11 years

• Highly experienced in testing solid dosage forms for stability following established SOP’s and ICH guidelines

• Experienced in testing drug device for assay, impurity and drug release

• Experienced in validation of dissolution, potency and impurity methods by HPLC

• Reviewed GMP analytical data such as laboratory notebooks, validation protocols and reports, method transfer reports, certificate of analysis, stability summary reports, and test methods

• Experienced in transferring analytical methods to contract and QC Laboratories

• Experienced in writing validation protocols, validation reports, method transfer protocol and reports, stability summary reports and test methods

• Experienced in the initiation and investigation of OOS/OOT results and writing investigation and deviation reports

• Initiated change controls and revised test methods and SOP’s

• Provided analytical support to formulation development

• Supported test methods development

• Experienced in operating HPLC, GC, GPC, UV-VIS Spectrophotometer, Dissolution Units (Manual and Auto) and in trouble shooting analytical and instrumental problems

• Involved in the calibration of analytical instruments

• Experienced in training junior chemists

• Worked in LABWARE LIMS system

• Experienced in Empower, Chemstation, Totalchrom and Cerity softwares

Knowledge

Sound knowledge of current Good Manufacturing Practices

Knowledge in ICH guidelines relevant to analytical method validation, testing and stability studies

Knowledge in general analytical chemistry and USP test methods

Skills

Excellent documentation skills

Good verbal and written communication skills

Very organized

Good in working independently as well as part of a team

Flexible and hard working

Fast learner

Professional Experience (Pharmaceutical)

Analytical Chemist ( July 2011 to present)

Xenoport, Inc.

Santa Clara CA 95051

• Involving in analytical support to formulation development

Analytical Chemist (October 2009 to June 2011)

Abbott Vascular, Santa Clara, CA 95054

• Testing vascular stents for assay, impurities and drug release for clinical release and engineering study

• Reviewing laboratory notebooks

Research Associate III

Durect Corporation, Cupertino, CA 95014

Sep 2006 to October 2009

• Conducting stability testing of drug product for dissolution, assay and impurities

• Performing validation of analytical methods

• Involving in analytical method transfers activities

• Involving in analytical support to formulation development

• Supporting test methods development

• Writing validation protocols and reports, method transfer protocols and reports and test methods

• Initiating change controls and revising test methods and SOP’s

• Initiating and investigating OOT/OOS results and writing investigation and deviation reports

• Reviewing laboratory notebooks

• Involving in the inventory of controlled drug substances

Chemist IV (August 2000 – June 2006)

Apotex Inc., Toronto, Canada

• Conducting stability testing of drug product for hardness, friability, moisture, dissolution, assay and impurity

• Performing validation of analytical methods

• Involving in analytical method transfers

• Reviewing GMP laboratory notebooks, validation protocols and reports, method transfer protocols and reports, C of As and stability summary reports

• Writing stability reports, validation protocols and reports and method transfer protocols and reports

• Initiating and investigating OOT/OOS results and writing investigation and deviation reports

• Initiating change controls and revising test methods and SOP’s

• Training new chemists to perform testing and training SOPs in the department

• Trouble shooting analytical and instrumental problems

Hands on Experience on the following instruments

• HPLC

• GC

• GPC

• Dissolution Test Apparatus

• UV-VIS spectrophotometer

• IR

Professional Experience (NON PHARMACEUTICAL)

Research Fellow: 1990 -1995

Chemistry Group, Regional Research Laboratory, Council of Scientific and Industrial Research

India

EDUCATIONAL BACKGROUND

M.Sc (Applied Chemistry)

Cochin University of science and Technology, Kerala, India

AWARDS & Publications

Awarded Junior Research Fellowship by the Council of Scientific and Industrial Research, India and published papers in journals

References

Available upon request

Contact this candidate