Vivek V Mandal
Singapore
Summary
- To apply my background and skills in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) across diverse applied markets, including Pre-clinical and clinical Bioanalytical Science 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.Proven expertise in providing technical support, conducting training, and collaborating with internally and sponsor to deliver effective analytical solutions. Strong communicator with a passion for advancing scientific knowledge and enhancing customer satisfaction.
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 extraction method and sample preparation and quantitative analysis 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
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Implemented quality control measures to ensure the accuracy and reliability of experimental results.
- Designed experiments using appropriate controls and variables, resulting in valid conclusions being drawn from collected data.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Consulted with researchers to analyze problems, recommend technology-based solutions and determine computational strategies.
Analytical Researcher 1
Teva Pharmaceutical
06.2021 - 07.2022
- 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.
- Lead the studies submission to USFDA and EMA.
- Prepared and reviewed bioanalytical validation protocols and reports.
- Investigated and identified the root cause of deviation, out of specification (OOS) and out of trend (OOT) and implement CAPA.
- Reviewed technical and professional publications and journals to stay current on recent literature and make more strategic research decisions.
- Gathered and organized information for method developments purposes.
- Maintained detailed records of experimental procedures, observations, and results for accurate reporting and replication purposes.
Research Associate
Lupin Bioresearch Center (LBC)
09.2017 - 06.2021
- 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 - 08.2017
- 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 - 09.2015
- 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
●Strong knowledge of bioanalytical methods and techniques, including chromatography, mass spectrometry
● Developed and validated LC-MS/MS based analytical methods for overall bioanalytical studies including MS/MS parameter optimization, tuning of analytes in GLP environment
● Ability to oversee projects and completed Clinical BA/BE studies and Pre-clinical PK/TK studies from initiation, QC/QA inception to completion, including planning, execution, and resource management
● Precision in data handling and reporting to ensure high-quality results and Experience in managing and coordinated with multiple project requests, managing timelines budgets and resources, to streamline the analytical process and ensure timely completion
● Strong verbal and written communication abilities to convey complex information clearly to both technical and non-technical stakeholders
● Proficiency in data interpretation and statistical analysis, along with experience in software tools like Veeva, R3 and LIMS (LabVantage) used for bioanalytical data processing
●Experience in handling LC-MS-MS Waters TQS-Micro,TQ Absolute Waters-QPXE, Sciex TQ 4500, Sciex TQ 6500 and Sciex TQ 6500 with Analyst Software 163 Analyst Software 171 and Waters Masslynx
● Ability to identify issues, troubleshoots problems, and implements effective solutions in a fast-paced environment
Languages
English
Hindi
Marathi
Corporate achievements
- 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 continue rating Performance above Plan in Year 2019 and 2020 in endogenous and non endogenous molecule.
Personal Information
- Date of Birth: 07/07/1991
- 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 Dantamajan 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.
- 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
DECLARATION
I hereby declare that the information furnished above is true to the best of my knowledge. Vivek. V. Mandal
Timeline
Scientist, Biochemistry
Vectura Fertin Pharma Pte Ltd.
07.2022 - Current
Analytical Researcher 1
Teva Pharmaceutical
06.2021 - 07.2022
Research Associate
Lupin Bioresearch Center (LBC)
09.2017 - 06.2021
Trainee Research Associate
Lupin Bioresearch Center (LBC)
09.2016 - 08.2017
Trainee (Intern for 3 Months)
USV Private Limited
05.2015 - 09.2015
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
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