Highlights:1) Participated in more than 250 bio equivalence studies for various regulatory regions like HEALTH CANADA, US-FDA, MHRA, TGA, and EMA &ICH. 2) Worked for more than 50 analytical method developments and validations Applies assay for the routine batch analysis of drugs and metabolites in biological fluids using protein precipitation, Liquid-liquid extraction and solid phase extraction analytical techniques. 3) Well familiar with data handling using EMPOWER, “WATSON LIMS” 7.0&7.3 data interpretation. 4) Well versed in method development, method validation and study sample analysis using LC/MS/MS (API3200,4000 & 5500 with analyst software version 1.4.1, 1.4.2, 1.5, 1.5.1 &1.6.2) and HPLC (Agilent 1100,1200) with CTC PAL ROBOTIC SYSTEM & Shimadzu UHPLC NEXERA coupled with LC-MS/MS API5500. 5) Well familiar with general laboratory equipment with UV/VIS Spectrophotometer, FTIR,KF titration, Dissolution, Disintegration, Friability, Hardness, Flame photometry Microbalance, pH meter, etc…… 6) Participated as team member in facing US FDA, MHRA, EMA audits. 7) Interpret ate and solve queries given by quality assurance. 8) Assists with the preparation of screening and study documentation for data collection. 9) Assists with booking volunteers for screening activities and follow-up appointments. 10) Participates in the receipt, dispensation and inventory of test articles with C of A. 11) Facilitates ordering Test Article, receipt of Test Article storage, login/out, and preparation of related Test Article documentation and packaging. 12) Requests Dosing Scheme and ensures the entry of all Test article information into database. Prepares documents required for doing in coordination with the pharmacokinetic associate. 13) Assists with protocol. 14) Performing site preparation for initiation, conducting and close out in accordance with clinical trials. 15) Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects. 16) Assists providing monitoring visits, site management and ensures clinic staff activities for compliance with protocols, and SOPs. 17) Assists with the collection, reviewing and summarizing of clinical data and compilation of the clinical report. 18) Assists with the distribution of test articles to subjects as delegated by the Study Coordinator.

Skills:LC-MS/MS, DMPK, BIOANALYTICAL,, ANALYTICAL METHOD DEVELOPMENT, VALIDATION, BIOAVAILABILTY, BIOEQUIVALENCE, GLP, GCP, US FDA, API4000, API5500, WATSON LIMS,

Goal:To find continuous growth, and utilize my skills while providing professionalism and promoting company profit. To achieve a Challenging Position with a growth-oriented company that value high performance, professionalism and growth enhancement.

Membership:1) Certified register Pharmacist in India.

Certification:1) Participated in various In-house and outdoor training sections like Good laboratory practices, Good documentation practice, Good clinical practice, and Modern method of analytical techniques like LC-MS/MS, UHPLC-MS/MS Sponsored by Apotex research Pvt, Ltd., 2) Participated in the work shop on various systems and scope of GLP,SOPS, comparison between OECD&FDA GLPS, Facilities, Implementing GLP in organization, good documentation practices, Conduct of Bio analytical phase of a multi-site study as a test site and QA Inspection, computerized systems and validation in GLP environment, Facing a GLP inspection, conducted by Qualtox consultancy-2013 3) Participated in the work shop on Good Laboratory Practices conducted by Arkus clinical trial support solutions –Feb-2008. 4) Second International conference and Indo-Canadian satellite symposium on “pharmaceutical sciences, technology, practice and Natural health products” Feb-2007. 5) Attended the AICTE sponsored Quality Improvement Program on “Recent Advancements in Pharmaceutical Analysis” held at J.S.S. College of Pharmacy, Ooty, Tamilnadu.

Honor:1) M.Pharmacy Thesis titled “Bio-analytical method development and bio equivalence study of Amoxicillin and Clavulanic acid suspension by LC-MS. 2) B.Pharmacy Thesis titled “Formulation and evaluation of anti retroviral drugs loaded chitosan cross-linked micro spheres ” 1) Research paper entitled “Determination of Omeprazole in human plasma by LC-MS, An application to pharmacokinetic studies" was selected at the 58th IPC, Mumbai (December 2006). 2) Research paper entitled “Formulation and evaluation of anti retroviral drugs loaded chitosan cross-linked micro spheres ”was selected at second International conference and Indo-Canadian satellite symposium on “pharmaceutical sciences, technology, practice and Natural health products” (Feb-2007). J.S.S College of pharmacy, Ooty.

Research scientist-II 07/2012 - current
Apotex Research Pvt Ltd, Banglore, Karnataka India
Industry: Pharmaceutical
Under the supervision of Group leader, responsible for developing, validating bio-analytical methods for the quantification of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applies assay for analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques, Responsible for interpreting data and completing the required reports and documentation.
1)Conducts duties following established employer standard Operating procedures and in a consistent manner consistent with current regulatory (TPP, USFDA, TGA, ICH…etc….) guidelines/established practices/expectations. 2)Perform and monitor bio-analytical method development and validation for the quantification of drugs and metabolites. 3)Operates general laboratory equipment and instrumentation system and utilizes automated data collection/reporting system. 4)Sets-up and ensures calibration of analytical system and maintains instrument system in good working order. 5)Documents all the work and results of all assignments as required. 6)Preparation of lab reports (analytical method summary, validation reports, bio study reports.. etc…….) and also review of the reports. 7)Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management. 8)To write and revise SOPs as per need and maintain awareness of and adherence to all current SOPs. 9)Ensures that all work is preformed in compliance with all pertinent SOP, GLPs, GDP and safe work practices. 10)To over see the raw data compilation and their archiving after completion of final reports. 11)Performs routine maintenance on Mass Spectrometers and associated HPLC equipment. 12)Applies assay for the routine batch analysis of drugs and metabolites in biological fluids using protein precipitation, Liquid-liquid extraction and solid phase extraction analytical techniques. 13)Performs additional related duties as assigned by Management.--
Research scientist-I 05/2009 - 07/2012
Apotex Research Pvt,Ltd.,, Bangalore, Karnataka India
Industry: Pharmaceutical R&D
Under the supervision of Group leader, responsible for developing, validating bio-analytical methods for the quantification of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applies assay for analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques, Responsible for interpreting data and completing the required reports and documentation.
1)Conducted duties following established employer standard Operating procedures and in a consistent manner consistent with current regulatory (TPP, USFDA, TGA, ICH…etc….) guidelines/established practices/expectations. 2)Perform and monitor bio-analytical method development and validation for the quantification of drugs and metabolites. 3)Operates general laboratory equipment and instrumentation system and utilizes automated data collection/reporting system. 4)Sets-up and ensures calibration of analytical system and maintains instrument system in good working order. 5)Documents all the work and results of all assignments as required. 6)Preparation of lab reports (analytical method summary, validation reports, bio study reports.. etc…….) and also review of the reports. 7)Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management. 8)To write and revise SOPs as per need and maintain awareness of and adherence to all current SOPs. 9)Ensures that all work is preformed in compliance with all pertinent SOP, GLPs, GDP and safe work practices. 10)To over see the raw data compilation and their archiving after completion of final reports. 11)Performs routine maintenance on Mass Spectrometers and associated HPLC equipment. 12)Applies assay for the routine batch analysis of drugs and metabolites in biological fluids using protein precipitation, Liquid-liquid extraction and solid phase extraction analytical techniques. 13)Performs additional related duties as assigned by Management.--
Bio analytical assistant 05/2008 - 05/2009
Apotex Research Pvt, Ltd.,, Bangalore, Karnataka India
Industry: Pharmaceutical R&D
Under the supervision of Group leader, responsible for developing, validating bio-analytical methods for the quantification of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applies assay for analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques, Responsible for interpreting data and completing the required reports and documentation.
1)Conducts duties following established employer standard Operating procedures and in a consistent manner consistent with current regulatory (TPP, USFDA, TGA, ICH…etc….) guidelines/established practices/expectations. 2)Perform and monitor bio-analytical method development and validation for the quantification of drugs and metabolites. 3)Operates general laboratory equipment and instrumentation system and utilizes automated data collection/reporting system. 4)Sets-up and ensures calibration of analytical system and maintains instrument system in good working order. 5)Documents all the work and results of all assignments as required. 6)Preparation of lab reports (analytical method summary, validation reports, bio study reports.. etc…….) and also review of the reports. 7)Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management. 8)To write and revise SOPs as per need and maintain awareness of and adherence to all current SOPs. 9)Ensures that all work is preformed in compliance with all pertinent SOP, GLPs, GDP and safe work practices. 10)To over see the raw data compilation and their archiving after completion of final reports. 11 Performs routine maintenance on Mass Spectrometers and associated HPLC equipment. 12)Applies assay for the routine batch analysis of drugs and metabolites in biological fluids using protein precipitation, Liquid-liquid extraction and solid phase extraction analytical techniques. 13)Performs additional related duties as assigned by Management.--
Trainee Bio analytical assistant 02/2007 - 05/2008
Apotex Research Pvt,Ltd.,, Bangalore, Karnataka India
Industry: Pharmaceutical R&D
Under the supervision of Group leader, responsible for developing, validating bio-analytical methods for the quantification of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applies assay for analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques, Responsible for interpreting data and completing the required reports and documentation.
1 Conducts duties following established employer standard Operating procedures and in a consistent manner consistent with current regulatory (TPP, USFDA, TGA, ICH…etc….) guidelines/established practices/expectations. 2)Perform and monitor bio-analytical method development and validation for the quantification of drugs and metabolites. 3)Operates general laboratory equipment and instrumentation system and utilizes automated data collection/reporting system. 4)Sets-up and ensures calibration of analytical system and maintains instrument system in good working order. 5)Documents all the work and results of all assignments as required. 6)Preparation of lab reports (analytical method summary, validation reports, bio study reports.. etc…….) and also review of the reports. 7)Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management. 8)To write and revise SOPs as per need and maintain awareness of and adherence to all current SOPs. 9)Ensures that all work is preformed in compliance with all pertinent SOP, GLPs, GDP and safe work practices. 10)To over see the raw data compilation and their archiving after completion of final reports. 11)Performs routine maintenance on Mass Spectrometers and associated HPLC equipment. 12)Applies assay for the routine batch analysis of drugs and metabolites in biological fluids using protein precipitation, Liquid-liquid extraction and solid phase extraction analytical techniques. 13)Performs additional related duties as assigned by Management.--
PART TIME CHEMIST 03/2006 - 02/2007
Center for Advanced Drugs Research and testing (CADRAT) laboratory (bioequivalence center), Ooty, Tamilnadu India
Industry: J.S.S College of pharmacy,
Under the supervision of Group leader, responsible for developing, validating bio-analytical methods for the quantification of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applies assay for analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques, Responsible for interpreting data and completing the required reports and documentation.
1) Assists with the preparation of screening and study documentation for data collection. 2)Assists with booking volunteers for screening activities and follow-up appointments. 3)Participates in the receipt, dispensation and inventory of test articles with C of A. 4)Facilitates ordering Test Article, receipt of Test Article storage, login/out, and preparation of related Test Article documentation and packaging. 5)Requests Dosing Scheme and ensures the entry of all Test article information into database. Prepares documents required for doing in coordination with the pharmacokinetic associate. 6)Assists with protocol. 7)Performing site preparation for initiation, conducting and close out in accordance with clinical trials. 8)Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects. 9) Assists providing monitoring visits, site management and ensures clinic staff activities for compliance with protocols, and SOPs. 10)Assists with the collection, reviewing and summarizing of clinical data and compilation of the clinical report. 11)Assists with the distribution of test articles to subjects as delegated by the Study Coordinator.--

The Tamilnadu Dr M.G.R. Medical University, Chennai. 10/2001 - 10/2004
Chennai, Tamilnadu, India
Degree: Bachelor's Degree
Major:Pharmacy
B. Pharmacy (2000-2004) from VEL’S College of pharmacy, Chennai, Tamilnadu, affiliated to The Tamilnadu Dr M.G.R. Medical University, Chennai. B.Pharmacy Thesis titled “Formulation and evaluation of anti retroviral drugs loaded chitosan cross-linked micro spheres ”

Bio analytical scientist LC-MS/MS, GLP,GCP, Research Scientist, Research chemist