SENTHIL KUMAR.M
Principal Scientist
Bangalore
Summary
Passionate scientific leader with over 15 years of expertise in the pharmaceutical sector in the drug metabolism and pharmacokinetics (DMPK) field, as well as hands-on knowledge in bio-analysis, biotransformation, and in vitro investigations. Skilled in leading teams and managing projects at various phases of drug research, fostering creativity and constructing and keeping high-performing teams. Well-versed in people development, performance management, accelerating processes, and producing high-quality product in a timely way to facilitate decision making. Outstanding reputation for swiftly addressing scientific issues, enhancing customer happiness, fostering operational excellence, and demonstrating empathy in leadership.
Overview
19
19
years of professional experience
10
10
years of post-secondary education
1
1
Certification
Work History
Principal Scientist
Biocon Bristol Myers Squibb R&D Centre, Syngene International Limited
Bangalore
10.2022 - Current
- Responsible for leading a team of 4 scientists and directing overall efforts to provide timely and quality bioanalytical data for research projects from identification to candidate selection
- Responsible for integrated programmes such as optimization method development, coordination with invitro scientists, and PK data interpretation
- Expert in the quantitative estimation of small molecules including pro-drugs and biomarkers
- Leading the core team responsible for optimal and timely support for DMPK and efficacy studies
- Lead the efforts to generate 20%+ efficiency through in automation in sample processing and documentation
- Leading departmental efforts to implement Quality Management System
- Collaborating with business development team to develop the pricing strategy for various bioanalytical and ADME studies
- Working closely with project management team to ensure appropriate customization and optimal resource utilization
- Representing DMPK department for organization initiative for operational excellence
- Departmental representative for understanding hazard identification,riskassessment,preparation of documentfor job safety analysis and instrument
- Resource modelling and capacity planning to ensure optimal utilization of resources
- Successfully faced audit from BMS
- Significant contributions towards implementation of eLN, setting up micro-sampling and designing a user-friendly dashboard for tracking the ongoing studies.
Senior Research Scientist
Biocon Bristol Myers Squibb R&D Centre, Syngene International Limited
Bangalore
01.2018 - 10.2022
- Responsible for leading a team of 2 scientists and directing overall efforts to provide timely and quality bioanalytical data for research projects from identification to candidate selection
- Responsible for generating and reviewing quality bioanalytical data for research projects from pre-clinical studies
- Expert in bioanalysis of various prodrugs
- Understand various types of prodrugs and their bioanalytical challenges like ex-vivo stabilization strategies
- Metabolite identification studies in various matrices including but not limited to microsomes, S9 fraction and hepatocytes using latest LC-MS technologies
- Significant contributions towards improving throughput of assays
- Established reaction phenotyping experiments to decipher responsible enzyme for metabolism of lead candidates through recombinant CYPs and chemical inhibitors
- Established workflow of using selexion to resolute peak of positional isomers
- Responsible for ensuring everyone in the laboratory follows general safety rules
- Mentored new joiners covering concepts of pharmacokinetics, bioanalysis and biotransformation
- Authored/co-authored 5 research papers in peer reviewed journals
- (details available on https://scholar.google.com).
Research Scientist
Biocon Bristol Myers Squibb R&D Centre, Syngene International Limited
Bangalore
01.2016 - 06.2018
- Responsible for leading a team of 1 scientists and directing overall efforts to provide timely and quality bioanalytical data for research projects from identification to candidate selection
- Responsible to meet bioanalytical needs of the drug discovery project teams
- Responsible for data qulity,integrity and turnaround time of bioanalytical data from the team
- Accountable to maintain performance matrix of equipment and UPLC-MS/MS
- Responsible for Lab modification and LCMSMS instrumnet room modification
- Responsible for ERT(Emergency response team )
- Responsible for analysing preclinical PK and bioanalytical data.
Senoir Research Associate
Biocon Bristol Myers Squibb R&D Centre, Syngene International Limited
Bangalore
01.2011 - 06.2016
- Responsible for data qulity,integrity and turnaround time of bioanalytical data from the team
- Accountable to maintain performance matrix of equipment and UPLC-MS/MS
- Developed the LC-MS/MS technique on 10 BMS molecules daily and reported results within two days
- BMS scientiest given training abouut bioanaltical tecniques like instrumenataion UPLC-MS/MS µsampling(DBS cards)
Research Associate
Biocon Bristol Myers Squibb R&D Centre, Syngene International Limited
Bangalore
10.2007 - 06.2011
- Worked as a bio-analytical scientist in the DMPK department (non GLP lab)
- Responsible for regular calibration of instruments
- Developed and validated various bio-analytical methods
- Prepared SOPs for various instruments
- Successfully faced internal audit from Bristol Myers Squibb(USA).
Executive
R, D CENTER, Andheri
Mumbai
04.2007 - 09.2007
- Performing Bioanalytical method development , Method Validation and Routine batch sample analysis in human body fluids by quantification of drugs and metabolites by LC-MS/MS
- Investigation and correction of analytical, instrumental and procedural problems
- Gearing up the organisation for USFDA audits
- Coordinate with Pharmacokinetics and Clinical Department for Biostudy related issues
- Leading a team of qualified personnel towards efficient Bioanalysis.
Executive
Wellquest clinical Research lower parel, Good Labratory
Mumbai
05.2005 - 03.2007
- Practice-LAB
- Bioanalytical and Analytical HPLC and LC-MS/MS Method Developments, Validations and Subject sample assays in human
- Facing extensive audits from clients.(USFDA,ANVISA)
- Authoring System related SOP’s and Method STP’s.
Education
Ph.D. - Pharmaceutical Chemistry
JSS College of Pharmacy,
OOTY,INDIA 01.2018 - 02.2022
Master of Science - Pharmaceutical Analysis
JSS College of Pharmacy
OOTY,INDIA 04.2003 - 03.2005
Bachelor of Science - Pharmacy
JSS College of Pharmacy
OOTY,INDIA 03.1998 - 06.2002
Skills
Bio-analytical Method Development and Validationundefined
Certification
Adept handling, troubleshooting of MDS-Sciex –API 4000 Q Trap (Analyst Ver. 1.4.2),7500 Q Trap (Sciex-OS) 5500 Q Trap (Analyst Ver. 1.5) and Xevo TQ-XS with Waters Aquity UPLC as frontend, Thermo orbitrap Additional Softwares. Shimazu HPLC and Shimazu LC-MS
Timeline
Principal Scientist
Biocon Bristol Myers Squibb R&D Centre, Syngene International Limited
10.2022 - Current
Ph.D. - Pharmaceutical Chemistry
JSS College of Pharmacy,
01.2018 - 02.2022
Senior Research Scientist
Biocon Bristol Myers Squibb R&D Centre, Syngene International Limited
01.2018 - 10.2022
Research Scientist
Biocon Bristol Myers Squibb R&D Centre, Syngene International Limited
01.2016 - 06.2018
Senoir Research Associate
Biocon Bristol Myers Squibb R&D Centre, Syngene International Limited
01.2011 - 06.2016
Research Associate
Biocon Bristol Myers Squibb R&D Centre, Syngene International Limited
10.2007 - 06.2011
Executive
R, D CENTER, Andheri
04.2007 - 09.2007
Executive
Wellquest clinical Research lower parel, Good Labratory
05.2005 - 03.2007
Master of Science - Pharmaceutical Analysis
JSS College of Pharmacy
04.2003 - 03.2005
Bachelor of Science - Pharmacy
JSS College of Pharmacy
03.1998 - 06.2002
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