Summary
Overview
Work History
Education
Skills
Languages
Corporateachievements
Personal Information
Training
Activities
Timeline
Generic

Vivek V Mandal

Singapore

Summary

To apply my background and skills in Pre-clinical and clinical Bioanalytical Science to provide efficient solutions in Spectrometry, Chromatography and Clinical research and development sector where my expertise in BA/ BE and other Bioanalytical technique will be utilized. To gain a substantial amount of successful exposure in the field of Pharmaceuticals and Clinical Trial sector by enhancing my ability to work in a professional environment managing my own work and producing result to the high standards required in accordance with GLP and GCP.

Overview

9
9
years of professional experience

Work History

Scientist, Biochemistry

Vectura Fertin Pharma Pte Ltd.
07.2022 - Current
  • Method Development and Validation: Performed method development, optimization, validation and study sample analysis of bioanalytical methods and oversee to ensure compliance with regulatory standards
  • Developed Method for different biological matrix like Plasma, tissue, urine, serum and blood for analytes and its metabolites
  • Project Oversight: Manage multiple bioanalytical projects, coordinating timelines, resources, and deliverables to meet project milestones
  • Regulatory Compliance: Ensure all bioanalytical activities comply with relevant regulatory guidelines (e.g., GLP, GCP, and FDA/EMA requirements)
  • Data Management: Supervise data analysis and interpretation, ensuring accuracy and integrity of results, and prepare and reviewed MV protocol and reports, Study phase plan and report for internal and external Stakeholders as subject matter expert
  • Team Leadership: Lead and mentor a team of scientists and technicians, fostering professional development and ensuring adherence to best practices
  • Collaboration: Work closely with cross-functional teams, including Preclinical, Study management, Invivo team, quality assurance, and regulatory affairs, to support overall project objectives
  • Quality Assurance: Implement and maintain quality control measures, part of audits, and address any deviations to ensure high-quality outputs
  • Resource Management: Manage laboratory resources, including budgeting, procurement, and maintenance of equipment
  • Continuous Improvement: Identify opportunities for process improvements and implement best practices in bioanalytical procedures
  • Stakeholder Communication: Communicate findings and project progress to senior management and clients, providing insights and recommendations as needed
  • Hand highly sensitive molecules during development, validation and study sample analysis

Analytical Researcher 1

Teva Pharmaceutical
06.2021 - Current
  • Part research and development of new analytical methods, validation and study sample analysis of endogenous molecule on LC-MS/MS
  • Simultaneously developed method for endogenous and non endogenous molecule together in single method on LC-MS/MS
  • Hand highly sensitive molecules during development, validation and study sample analysis

Research Associate

Lupin Bioresearch Center (LBC)
09.2017 - Current
  • Performed different extraction techniques like LLE, SPE and PPT for extraction of sensitive molecules from different matrix in Method Development, Method Validation and Study Sample Analysis
  • To carry out Literature survey, perform tuning of molecules and different extraction trial from biological matrix in method development under regulatory environment
  • Research and development of new analytical methods, validation of new and current methods, write Procedure, review analytical data, prepares reagent, routine LC-MS-MS
  • Optimization of LC parameters including column and mobile phase selection, isocratic and gradient elution
  • Prepared calibration standard and QC sample
  • Maintain special safety requirement to ensure no contamination from step during handling sensitive molecules
  • Selection, handling and usage, retrieval and storage of APIs and its deuterated standards according to in-house SOPs
  • Experience of handling Scientific Data management System (SDMS) software by Waters
  • Calibration, maintenances, and trouble shot on LC-MS-MS instruments
  • Prepared analytical reports for validation and biological studies
  • Ability to lead, co-ordinate and manage multiple projects
  • Having a quality check of the raw data before it is submitted to the quality assurance team
  • Effective communication with cross functional departments and sponsor
  • Experience with FDA, GLP and OECD guidelines
  • Highly efficient Data recording and reporting under GLP and SOP specifications

Trainee Research Associate

Lupin Bioresearch Center (LBC)
09.2016 - Current
  • To perform calibration of instruments such as analytical balance, pH meter
  • Recording and reporting the temperature and humidity throughout the laboratory according to in-house SOP
  • To carry out and perform pipette calibration, weighing of API’s, preparation of solutions as mentioned in the draft/approved analytical procedures
  • Ensuring that study is being conducted according to the study protocols before study initiation
  • Handling and Documentation of retrieval and re-storage of study sample according to in-house SOPs
  • Recording and reporting the documentation following good documentation practices
  • To carry out analysis of study samples using extraction techniques such as solid phase extraction, liquid- liquid extraction and precipitation techniques
  • Issuance of raw data forms according to in-house SOP
  • To strictly follow SOPs, GCP and GLP

Trainee (Intern for 3 Months)

USV Private Limited
05.2015 - Current
  • Biotechnology research laboratory on proteins and peptide

Education

M.Sc. - Five Year Integrated Course In Bioanalytical Sciences

Ramnarain Ruia College, University Of Mumbai
06.2016

B.Sc. - Five Year Integrated Course In Bioanalytical Sciences

Ramnarain Ruia College, University Of Mumbai
06.2014

H.S.C -

Elphistone College Fort
06.2010

S.S.C -

N.K.E.S High school Wadala
06.2008

Skills

  • Bioanalytical methods
  • Chromatography
  • Mass spectrometry
  • Bioanalytical regulatory guidelines
  • Compliance
  • Quality assurance
  • Project management
  • Data interpretation
  • Statistical analysis
  • Bioanalytical data processing
  • Team management
  • Problem solving
  • Data handling
  • Reporting
  • Communication
  • Bioanalytical technologies
  • LC-MS-MS
  • Analyst Software
  • Waters Masslynx
  • Method validation
  • Pharmacokinetic studies
  • MS/MS parameter optimization
  • GLP environment

Languages

English
Hindi
Marathi

Corporateachievements

  • Awarded the most promising fresher in Lupin Learning Center during induction training.
  • Received work of excellence for being a part in first to file of a molecule in the year 2017.
  • Received a continue rating Performance above Plan in Year 2019 and 2020 in Lupin.
  • Received a Teva Silver Star twice for Method development and Validation for endogenous and non endogenous molecule.

Personal Information

  • Date of Birth: 07/07/91
  • Nationality: Indian

Training

  • National Seminar on 'Advances in Bio-imaging and lab safety training.'
  • Workshop on 'Analytical Techniques in Genomics and Proteomics' jointly conducted by Ramnarian Ruia College, Mumbai and Central Dogma Pvt Ltd, Pune.
  • Safety in 'Chemical Handling and Laboratory working' organized by Safety and Security Committee of Ramnarian Ruia College.
  • CGCP training on Bioavailability and Bioequivalence Studies Conducted by Lupin Bioresearch Center.

Activities

  • HERBAL DANTAMANJAN FORMULATION, It is a formulation made of herbal products like Curry leaves, Tulsi and Pudina Leaves. It has calming effect and is effective on mouth micro-organism., 03/01/13 to 02/01/14
  • Phytochemical variation in different Dates (Phoenix dactylifera), Biochemical test was performed on Dates for detection of sugar, protein, fats and minerals to study the change in fruits from different region.

Timeline

Scientist, Biochemistry

Vectura Fertin Pharma Pte Ltd.
07.2022 - Current

Analytical Researcher 1

Teva Pharmaceutical
06.2021 - Current

Research Associate

Lupin Bioresearch Center (LBC)
09.2017 - Current

Trainee Research Associate

Lupin Bioresearch Center (LBC)
09.2016 - Current

Trainee (Intern for 3 Months)

USV Private Limited
05.2015 - Current

B.Sc. - Five Year Integrated Course In Bioanalytical Sciences

Ramnarain Ruia College, University Of Mumbai

H.S.C -

Elphistone College Fort

S.S.C -

N.K.E.S High school Wadala

M.Sc. - Five Year Integrated Course In Bioanalytical Sciences

Ramnarain Ruia College, University Of Mumbai
Vivek V Mandal