Download PDF

Work experience

Scientist

Torrent Research Centre

Bio analytical Department

·Learned about basics of sample preparation, maintenance and calibration of instruments, preparation of SOP and reports, sample management (cold storage).

Analytical Department

·Disintegration test, dissolution, assay, related impurity and content uniformity test.

Research Associate

Drug Monitoring and Research Instituate

·Responsible for Method Development, validation and study sample analysis on API 3000 LC-MS/MS.

·Actively participated in bioanalytical lab set up, SOP preparation and training.

Executive

Sun Pharmaceutical

·Bio analytical Lab setup.

·Expanded Laboratory from one LCMSMS to four LCMSMS.

·Explored Winnonlin.

·Reduced cost of outsourced projects: Actively involved in selection of CRO and monitoring of outsourced projects.

Dec 2007Present

Deputy General Manager (Bio-analytical Department)

Accutest Research Lab (I) Pvt.Ltd

·Successfully completed different regulatory audits and sponsor audits with zero or minor findings.

·Audit faced USFDA, WHO, ANVISA, DCGI and Turkey.

·Developed some challenging methods which require derivatisation, pre stabilization (unstable molecules) and high sensitivity.

·Reduced sample cost and sample processing error: Optimized selection of processing method, materials and documentation.

·Reduced Instrument down time: Training, preventative maintenance and seminar.

·Project Management -Reduced project time line: Optimized flow of documentation and review cycles.

·Explored and Implemented use of modern, robotics and most sensitive Instrument like UPLC-MS/MS, Liquid Handling system.

·Discovered, developed and retained top talent.

·Supervised 3 to 6 group of Scientists and other supporting staff.

·Supervised some cross functional areas like sample management group, vendor selection and purchase.

Education

20102014

Ph.D 

K.B.Instituate of Pharmacy

HPLC -MSMS method development and validation of drugs acting on CVS and CNS systems, their application to Bioequivalence study sample analysis.

Mar 2002

M.Pharm

M.S.University , Baroda

Method development of Fluconazole

19952000

BPharm

B.K.Modi Govt Pharmacy College , Rajkot

Skills

Industrial guide
          Guided more than 10 M.Pharm students as Industrial Guide.         External Examiner:  GTU, Gujarat.       Advisory Panel Member (Industry):  K B Institute of Pharmaceutical Education & Research, Gandhinagar.      (Kadi University).  
Research Paper Review
  ·    Peer reviewer: Different Journals of Omics publishing group, Serial publication group and Academic Science group.  
Project Planning
Inventory Management
Winnolin(PK) Calculation
Cost Analysis and Cost effective Project Planning
People Management
Bioanalysis

References

Dr.Ashutosh Pudage

Venu Madhav Edupuganti

Summary

Regulated Bio analysis

Pharmacokinetic

CRO

Project Management

GLP

CustomSmall

Publications.

1. A UPLC–MS/MS method for the quantification of Olanzapine in human plasma —        A method for high- throughput.

2. A simple, selective and rapid validated method for determination of nicorandil in human plasma by liquid chromatography - tandem mass spectrometry