Summary
Overview
Work History
Education
Skills
Expertise
Regulatory Audits
Known Languages
Personal Information
Publications
Training
Vision Objective
Timeline
Generic

JIVAN WAGHMODE

Clinical research, Bioanalysis
Pune

Summary

A well-qualified graduate in pharmaceutical science carries fifteen years' experience with therapeutic expertise in Analytical needs of, Bioavailability and Bioequivalence Studies with regulatory compliance. Likes to work in a congenial environment which provides me an opportunity to sharpen my acquired skills and contribute positively in the progress of your esteemed organization.

Scientist with significant experience in research methodologies, data analysis, and project management. Strong team collaborator focused on driving impactful results and adapting to evolving project needs. Proficient in laboratory techniques, statistical software, and scientific writing. Known for reliability, problem-solving skills, and effective communication in collaborative environments. Analytical Research Specialist with experience in experimental research and data analysis. Detail-oriented and methodical professional successful in developing in-depth research projects. Reliable team player with excellent communication and problem-solving skills.

Overview

16
16
years of professional experience
2009
2009
years of post-secondary education

Work History

RESEARCH SCIENTIST

SYNAPSE LABS PVT LTD
Pune
03.2009 - 10.2024
  • Method development, Validation and Sample analysis and monitoring of PK parameters.
  • To ensure GLP and 21CFR part 11 compliance in the Laboratory.
  • To ensure CSV as per requirement of GAMP 5.
  • To interact and present data to regulatory auditors/ third party coordinator.
  • Preparation/review of SOPs.
  • Review and update/Implementation of the systems and procedures as per current regulatory requirements.
  • Cost optimization in the laboratory.
  • Ensure the Calibration and maintenance of all equipment's in the laboratory.
  • Communication with Service engineers for proper maintenance of the equipments in the laboratory.
  • Instruments and Equipments handled - Waters Quattro premier XE LC-MS-MS (s/w - Masslynx 4.1), API-3000 LC-MS-MS (Applied Biosystem) coupled with H.P.L.C.(Shimadzu) Analyst (s/w 1.6.2), API-4500 LC-MS-MS (Applied Biosystem) coupled with U.P.L.C.(Agilent) Analyst (s/w 1.7.2), Hot air Oven, Incubator, Sonicator, Micro balance, Semi micro balance, Eurotherm temperature monitoring system, Deep freezers.
  • EXPERTISE IN METHOD DEVELOPMENT: Method development and validation for generic drugs as per EU, MHRA and USFDA guidelines.
  • Method development and validation for poorly ionisable molecules by use of chemical derivatization approach. (e.g. Free ezetimibe)
  • Method development and validation for positive and Negative ionisable compounds.
  • Developed method of Fludrocortisone, Isosorbide mononitrare by using adduct form.
  • Developed method with simultaneous positive and negative polarity switching. (e.g. Amiloride & Hydroclorothiazide, Metoprolol and Pravastatin).
  • EXPERTISE IN METHOD VALIDATION: Method validation done for generic drugs as per EU, MHRA and USFDA guidelines.
  • Validated method with simultaneous positive and negative polarity switching. (e.g. Amiloride & Hydroclorothiazide, Metoprolol and Pravastatin).
  • EXPERTISE IN Analysis of samples: Expertise in developing methods in different matrix, e.g. Plasma, Blood, serum.
  • Bioanalytical method development and Validation for generic drugs using LC-MS/MS, for application to Pharmacokinetic studies in Human according to regulatory guidelines.
  • Study samples analysis- Method development, validation and study samples by using different extraction techniques which includes LLE, SPE and protein precipitation with compliance of regulatory requirements.
  • EXPERTISE IN Data generated in Analytical laboratory: Reviewed IQ, OQ and PQ of newly installed equipments.
  • Reviewed CSV reports generated for 21 CFR compliance system.
  • Reviewed more than 300 studies performed for bioequivalence of generic drugs.
  • DOCUMENTATION AND REPORT PREPARATION: Preparation of analytical report.
  • Giving feedback to queries and observations given by internal audit team and Quality control team.
  • Keep check on documentation done by team mates and presenting it to Synapse quality control team.
  • OTHER ROLES: Day to Day to planning of work in laboratory.
  • Report preparation of Bio analytical studies.
  • Maintenance of instruments and equipment's in bio analytical laboratory.
  • Inventory management for bio analytical laboratory.
  • Mentored junior scientists, fostering professional growth and enhancing team capabilities.
  • Streamlined research processes to meet tight deadlines for multiple projects.
  • Managed laboratory budgets effectively, allocating funds strategically for maximum impact on research outcomes.

Education

B. Pharm. -

Pune University

Skills

Laboratory techniques

Root-cause analysis

Scientific writing

Research planning

Documentation expertise

Results interpretation

Expertise

Method development and validation for generic drugs as per EU, MHRA and USFDA guidelines., Method development and validation for poorly ionisable molecules by use of chemical derivatization approach., Method development and validation for positive and Negative ionisable compounds., Developed method of Fludrocortisone, Isosorbide mononitrare by using adduct form., Developed method with simultaneous positive and negative polarity switching., Method validation done for generic drugs as per EU, MHRA and USFDA guidelines., Validated method with simultaneous positive and negative polarity switching., Expertise in developing methods in different matrix, e.g. Plasma, Blood, serum., Bioanalytical method development and Validation for generic drugs using LC-MS/MS, for application to Pharmacokinetic studies in Human according to regulatory guidelines., Study samples analysis- Method development, validation and study samples by using different extraction techniques., Reviewed IQ, OQ and PQ of newly installed equipments., Reviewed CSV reports generated for 21 CFR compliance system., Reviewed more than 300 studies performed for bioequivalence of generic drugs., Preparation of analytical report., Giving feedback to queries and observations given by internal audit team and Quality control team., Keep check on documentation done by team mates and presenting it to Synapse quality control team., Day to Day to planning of work in laboratory., Report preparation of Bio analytical studies., Maintenance of instruments and equipment's in bio analytical laboratory., Inventory management for bio analytical laboratory.

Regulatory Audits

Presented data successfully to EU, MHRA, NPRA and USFDA regulatory auditors

Known Languages

  • English
  • Hindi
  • Marathi

Personal Information

  • Date of Birth: 02/20/86
  • Marital Status: Married

Publications

Development of Simple and Rapid LC-MS/MS Method for Determination of Celecoxib in Human Plasma and its Application to Bioequivalence Study, Biomirror, 06/01/15, 6, 53-60, Waghmode Jivan, Jalakam Siva Prakash, Pawar Prashant, Shinde Dattajirao

Training

  • Good laboratory practice, Pharma Edge Center Pvt Ltd, 03/26/10
  • Basic Operation, Maintenance and Troubleshooting of LC-MS/MS, Mr. Ashutosh Kulkarni, Waters India Pvt. Ltd., 12/30/09
  • GLP, Dr. Shedbalkar
  • 21 CFR Part 11 training

Vision Objective

A well-qualified graduate in pharmaceutical science carries fifteen years' experience with therapeutic expertise in Analytical needs of, Bioavailability and Bioequivalence Studies with regulatory compliance. Likes to work in a congenial environment which provides me an opportunity to sharpen my acquired skills and contribute positively in the progress of your esteemed organization.

Timeline

RESEARCH SCIENTIST

SYNAPSE LABS PVT LTD
03.2009 - 10.2024

B. Pharm. -

Pune University

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JIVAN WAGHMODEClinical research, Bioanalysis