Bioanalytical Method developments,Validations,study sample analysis

G .VIJAYA KUMAR

Address: H.No. ***, Gulla reddy Layout, Behind Lakshmi Timber Depot, Anekal Road,

Chandapura, Bangalore 81

Mobile: +91-953******* Mail: *********************@*****.**.**

‘Exploring Leadership opportunities in Senior Level roles with Pharmaceutical Industry

Pharmaceuticals Bio analytical Bio analytical Quality Assurance

A competent Pharma industry professional with 10.8 years of extensive experience in with Pharmaceutical

Industry : Pharmaceuticals Bio analytical Bio analytical Quality Assurance

DOCUMENTATION REVIEW M AN MANAGEMENT METHOD DEVELOPMENT/VALIDATION

SYSTEM IMPLEMENTATION C OUNDUCTING TRAININGS L C-MS/MS AND HPLC HANDLING

BATCH SAMPLE ANLAYSIS QUALIFY ASSURANCE SOP PREPARAION/IMPLEMENTATION

EXECUTIVE SYNOPSIS

• Comprehensive experience in Bio-analytical Method developments, Validation and Study sample analysis, etc.

• Expertise in handling entire people management, method development as well as Quality assurance ensuring smooth

implementation

• Hands on experience in all technical aspects of the assigned projects, in the conduct of Bio-analytical method development,

validation and routine batch sample analysis of biological samples by using LC-MS/MS and HPLC, Watson LIMS

• Expert in motivating, training & guiding team members effectively with adaptability to work and handle pressure in required

situations as well as work in multi cultural environments

• Known for driving adherence to all procedures and regulatory requirements

Successful at managing performance and leading teams affectivity

SOFT SKILLS

ACADEMICS / CERTIFICATIONS/ IT SKILLS

MSC Organic Chemistry Andhra University, Vizag 2003

TRAININGS ATTENDED

Good Laboratory Practice workshop organized by Dr.Geetha Rajashekar 2013

Good Laboratory Practice workshop organized by Dr.Geetha Rajashekar 2012

Good Clinical Practice workshop organized by India-WHO 2011

Good Laboratory Practice workshop organized by Dr. Divan 2008

LC-MS/MS theory and practical training by Lab India

Other trainings by Waters India Ltd, Spinco Biotech Pvt. Ltd

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COMPUTER COMPEETENCIES

Analyst software 1.5.1.

HPLC Software's like, Shimadzu Class VP controlling software, Em-Power of waters and Chem Station of

agilent.

Watson LIMS software version 7.0.3.01

CA R E E R ACC O M P L I S H M E N T S

• Supervised all technical aspects of the assigned projects, in the conduct of Bio-analytical method development, validation and

routine batch sample analysis of biological samples by using LC-MS/MS and HPLC, Watson LIMS.

• Reviewed the documentation generated by direct reports as per standard operation procedures.

• Planned and monitored assigned project timelines. Ensures the completion of the assignment in a timely manner.

• Prepared project status reports and keep informed to bio-analytical Manager.

• Prepared responses for various regulatory agencies.

PROFESSI ONAL CONTOUR

Apotex Research Pvt Ltd,Bangalore May 2007 – Present

Career Path:

Team Leader Since April 2009

Apr 2008 - Mar 2009

Sr. Analytical Scientist

Bioanalytical Scientist May 2007 - Mar 2008

Aurobindo Pharma Ltd,Research Center- Hyderabad Jan 2004 - May 2007

Research Associate (Promoted from grade I - IV)

FUNCTIONAL ROLE

• Supervising all technical aspects of the assigned projects, in the conduct of Bioanalytical method development, validation and

routine batch sample analysis of biological samples.

• Review the documentation generated by direct reports as per standard operation procedures.

• Planning and monitoring assigned project timelines. Ensure the completion of the assignment in a timely manner.

• Preparing project status reports and keep informed to manager bioanalytical.

Functions handled in Previous Organizations:

• Engaged in the area of Bio-analytical method development/validation as per US-FDA guidelines

• Pivotal in the development and validation of over 50 assays using plasma and serum as the bio-matrices using LC-MS/MS and

HPLC instruments.

• Worked on about 200 bioequivalence and bioavailability studies which were submitted to various regulatory like US-FDA

(ANDA), EU, WHO, UK, Brazil, ANVISA,MCC and DCGI.

• Administered various operations such as Project Management, System Implementation and Coordination etc.

• Authored reports and SOP’s on Technical report outlining experiments and results for all bio analytical methods developed as

per GLP and ICH guidelines. Several SOP’s both in current position, and at past positions in Bio-analytical department.

• Successfully handled various audits such as, US – FDA, WHO, ANVISA of Brazil, MCC of South Africa,NABL of India and

other Europe regulatory body

OPERATIONS PURVIEW:

• LC-MS/MS systems of MDS Sciex ( API 2000,3000,3200,4000,5500), various makes of HPLCs like Agilent, Shimadzu, Perkin

Elmer, Konikrom, and Gilson etc.

PERSONAL DOSSIER

Date of Birth Languages Known: English, Hindi, Telugu and

: 12th February 1981

Kannada

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~ References Available upon Request ~

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