VIVEK VIJAY MANDAL
Scientist
Singapore
Summary
- I aim to achieve significant exposure in the clinical and non-clinical trail sector of Pharmaceuticals by improving my ability to work professionally while managing my tasks and delivering results that meet the high standards of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). I have proven expertise in providing technical support and training, as well as collaborating with internal and external sponsors to deliver effective Bioanalytical solutions. I am a strong communicator passionate about advancing scientific knowledge and enhancing customer satisfaction.
- I aim to leverage my background and skills in Liquid Chromatography-Mass Spectrometry (LCMS/MS) across various applied markets, particularly in the pre-clinical and clinical Bioanalytical Science research and development sector. My expertise in PK/PD, TK, DMPK, ADME and BA/BE Bioanalytical techniques will be effectively utilized in these areas.
Overview
10
10
years of professional experience
10
10
years of post-secondary education
3
3
Languages
Work History
SCIENTIST, BIOANALYTICAL
Vectura Fertin Pharma Pte Ltd.
07.2022 - Current
- Assay Development and Validation: Performed LC-MS/MS method development, optimization, validation and study sample analysis of bioanalytical methods and oversaw to ensure compliance with regulatory standards
- Developed extraction method and sample preparation and quantitative analysis for different biological matrices like Plasma, tissue, urine, serum and blood for analytes and their metabolites
- Project Oversight: Managed multiple bioanalytical projects, coordinating timelines, and resources, and delivering to meet project milestones
- Regulatory Compliance: Ensured all bioanalytical activities comply with relevant regulatory guidelines (e.g., GLP, GCP, and FDA/EMA/ICH requirements)
- Data Management: Supervised data analysis and interpretation, ensured accuracy and integrity of results, and prepared and reviewed MV protocol and reports, Study phase plan and report for internal and external (sponsors) Stakeholders as subject matter experts
- Team Leadership: Led and mentored a team of scientists and technicians, fostering professional development and ensuring adherence to best practices
- Collaboration: Worked closely with cross-functional teams, including Clinical, Preclinical, Study management, Invivo team, quality assurance, and regulatory affairs, to support overall project objectives
- Quality Assurance: Implemented and maintained quality control measures, part of audits, and addressed deviations to ensure high-quality outputs
- Resource Management: Managed laboratory resources, including budgeting, procurement, and equipment maintenance
- Continuous Improvement: Identified opportunities for process improvements and implemented best practices in bioanalytical procedures
- Stakeholder Communication: Communicated findings and project progress to senior management and clients, and provided insights and recommendations as needed
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation
- 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 a lab setting
- Consulted with researchers to analyze problems, recommend technology-based solutions and determine computational strategies
- Reviewed and compiled bioanalytical data results from validation and study sample analysis, making an initial determination on acceptability according to SOP acceptance criteria
- Identified the OOS, and OOT, and performed investigation processes
- Leads investigations and root cause analysis while proposing corrective and preventive actions (CAPAs)
- Hand highly sensitive molecules during development, validation and study sample analysis
ANALYTICAL RESEARCHER 1
Teva Pharmaceutical
06.2021 - 07.2022
- Researched and developed new analytical methods, validation and study sample analysis of nonendogenous and endogenous molecules 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 implemented 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 development purposes
- Maintained detailed records of experimental procedures, observations, and results for accurate reporting and replication purposes
- Monitored progress against project timelines, ensuring timely completion of deliverables while maintaining high-quality standards
- Provided technical guidance on experimental design and data interpretation issues for team members as needed
- Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations
- Conducted comprehensive literature reviews for foundational understanding, leading to groundbreaking insights
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 matrices in Method Development, Method Validation and Study Sample Analysis
- Conducted a Literature survey, and performed tuning of molecules and different extraction trials from the biological matrix in method development under a regulatory environment
- Researched and developed new analytical methods, validated new and current methods, wrote Procedures, reviewed analytical data, and prepared reagents, and routine LC-MS-MS
- Optimization of LC parameters including column and mobile phase selection, isocratic and gradient elution
- Prepared calibration standards and QC samples
- Maintained special safety requirements to ensure no contamination from step during handling sensitive molecules
- Selection, handling and usage, retrieval and storage of APIs and their deuterated standards according to in-house SOPs
- Experienced in handling Scientific Data Management System (SDMS) software by Waters
- Calibration, maintenance, and troubleshooting on LC-MS-MS instruments
- Prepared analytical reports for validation and biological studies
- Ability to lead, coordinate and manage multiple projects
- Performed a quality check of the raw data before it was submitted to the quality assurance team
- Effectively communicated with cross-functional departments and sponsors
- Experienced 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
- Performed calibration of instruments such as analytical balance, and pH meter
- Recorded and reported the temperature and humidity throughout the laboratory according to in-house SOP
- Carried out and performed pipette calibration, weighing of APIs, and preparation of solutions as mentioned in the draft/approved analytical procedures
- Ensured that the study was being conducted according to the study protocols before study initiation
- Handled and Documented retrieval and re-storage of study samples according to in-house SOPs
- Recorded and reported the documentation following good documentation practices
- Carried 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
- Strictly followed SOPs, GCP and GLP
- Supported departmental tasks to increase understanding of industry processes
- Enhanced trainee experience by developing comprehensive orientation programs and hands-on training sessions
- Completed comprehensive training modules to gain proficiency in industry-specific software, contributing to more efficient project execution
- Supported implementation of new technologies, leading to more efficient workflows
- Engaged in problem-solving activities with peers to develop critical thinking skills, enhancing team resilience
TRAINEE (INTERN FOR 3 MONTHS)
USV Private Limited
05.2015 - 09.2015
- Biotechnology research laboratory on proteins and peptides
Education
M.Sc. - Five-Year Integrated Course in Bioanalytical Sciences
Ramnarain Ruia College, University of Mumbai
06.2011 - 06.2016
B.Sc. - Five-Year Integrated Course in Bioanalytical Sciences
Ramnarain Ruia College, University of Mumbai
06.2009 - 06.2014
H.S.C - undefined
Elphinstone College Fort
S.S.C - undefined
N.K.E.S High school Wadala
Skills
Experienced in operating LC-MS/MS instruments, including Waters TQS Micro, TQ Absolute Waters-QPXE, Sciex TQ 4500, Sciex TQ 6500, and Sciex TQ 6500, using Analyst Software versions 163 and 171, as well as Waters MassLynx
Oversaw projects and completed clinical (BA/BE) and non-clinical (PK/TK) studies from initiation through QC/QA inception to completion This includes planning, execution, resource management, method development and validation, sample receipt, shipment, handling, analysis, storage, and data delivery and archiving
Excellent verbal, written communication and presentation skills to convey complex information to internal and external stakeholders, including sponsors and CROs, regardless of their technical background
Ability to identify issues, troubleshoot problems and implement effective solutions in a fast-paced environment
Experienced in managing and leading team members, and fostering a collaborative team environment
Responsible for the accurate, timely, and compliant execution of assigned projects, analytical testing, and related documentation
Deliver exceptional technical support, generate impactful development ideas, strengthen our global research portfolio, and drive effective research planning with confidence
Proficient in data interpretation and statistical analysis, with experience using software tools like Veeva, R3, and LIMS for bioanalytical data processing
Familiar with bioanalytical regulatory guidelines (eg, ICH-Bioanalytical/GCP, FDA, EMA, 21 CFR Part 11) and experienced with compliance and quality assurance processes
Developed and validated LC-MS/MS-based analytical methods for drugs and their metabolites in comprehensive bioanalytical studies, including MS/MS parameter optimisation and tuning of analytes in a GLP environment
Precision in data handling and reporting to ensure high-quality results Experienced in managing and coordinating multiple project requests and managing timelines, budgets, and resources to streamline the analytical process for timely completion
Committed to staying updated with advancements in LC-MS/MS and bioanalytical technologies and methodologies
Strong knowledge of bioanalytical methods, experiment design, assay development and techniques, including chromatography and mass spectrometry
Technical understanding of ELISA assay and immunoassay
Timeline
SCIENTIST, BIOANALYTICAL
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
M.Sc. - Five-Year Integrated Course in Bioanalytical Sciences
Ramnarain Ruia College, University of Mumbai
06.2011 - 06.2016
B.Sc. - Five-Year Integrated Course in Bioanalytical Sciences
Ramnarain Ruia College, University of Mumbai
06.2009 - 06.2014
H.S.C - undefined
Elphinstone College Fort
S.S.C - undefined
N.K.E.S High school Wadala
Languages
English
Hindi
Marathi
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 the 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 a calming effect and is effective on mouth micro-organisms.
- Phytochemical Variation in Different Dates (Phoenix dactylifera): A biochemical test was performed on Dates for the detection of sugar, protein, fats and minerals to study the change in fruits from different regions.
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge.
Corporate Achievements
- Awarded the most promising fresher in Lupin Learning Center during induction training.
- Received work of excellence for being a part of the first file of a molecule in the year 2017.
- Received a continued rating Performance above Plan in Years 2019 and 2020 in Lupin.
- Received a continued rating Performance above Plan in Years 2019 and 2020 in endogenous and non-endogenous molecules.