Manojkumar Dubey
Project Leader
Ahmedabad,GJ
Summary
Project Leader with 16+ years of experience in method development, method validation and study sample analysis for bioequivalence / comparative bioavailability studies using LC-MS/MS and HPLC systems for generic dosage and new drugs as per GCP/GLP guidelines.
Overview
18
18
years of professional experience
5
5
years of post-secondary education
Work History
Project Leader
Cliantha Research
Ahmedabad, Gujarat
07.2020 - Current
- Supervised a group of 12 scientists and handle more than 3 LC-MS/MS systems for conducting cost effective bioanalytical method development, validation and analysis of subject samples in biological matrix for various types of formulations.
- Served as Project Leader and overall responsible for the technical conduct of bio equivalence studies, method development and validation for various drugs and metabolites as well as for interpretation, analysis, documentation and reporting of the results in conformance to GLP guidelines.
- Review of Bioanalytical Data and preparation of Analytical Procedure sheets after successful completion of assay validation.
- Verification of Completeness of QC sheet and logbook entries as per the Protocol and/or SOPs.
- Familiar with HPLC and LC-MS/MS trouble shooting, data handling and interpretation.
- Successfully faced study specific regulatory audit of EU, USFDA, AFSSAPS, MCC and others.
- Performed Instrument Qualification (IQ, OQ and PQ) for LC-MS/MS software, which is a part of GLP requirement. Extensive hands on experience of tuning for various molecules.
- Preparation and review of SOPs and Overall lab delegation in-charge.
- To ensure effective implementation of GLP norms and proper follow up of In-house SOPs.
- Proactively collaborated with inter department to achieve continuous process improvement.
- Study Sample analysis of various drugs and/or their active metabolites by using different methods according to GLP guidelines and In-house SOPs for various regulatory submissions for ANDA & NDA filing.
- Responsible for initiating and handling the project within the timelines and reporting, reviewing the final study data for pilot and pivotal projects.
- Provided scientific and technical leadership, mentoring and guidance to the teammates and group members and to achieve the set targets.
- Maintenance and periodic calibration of Lab equipment like Analytical Balance, Centrifuge, HPLC systems, pH meters and LC-MS/MS systems.
- Imparting training to new entrants as well as subordinates regarding different aspects of Bio analytical work.
- Responsible for investigation of out of specification results.
- Managed team meetings and discussed project's goals and objectives.
- Observed progress of each project, examined risks and coordinated contingency plans.
- Adjusted project plans to account for dynamic targets, staffing changes and operational specifications.
- Maintained tactical control of project budgets and timelines to keep teams on task and achieve schedule targets.
- Collaborated with team members to develop, identify and accomplish assigned goals and objectives.
Manager
Cliantha Research
Ahmedabad, Gujarat
07.2016 - 06.2020
- Handled various makes of LC-MS/MS system like: APISciex-4000 &5500.
- Involvement in method development and method validation of drug molecules and its metabolites using LC-MS/MS.
- Study sample analysis of biological samples for BA/BE studies and various Pharmacokinetic studies.
- Ensure about GLP implementation in laboratory and faced GLP audits from various regulatory authorities like USFDA/ENVISA/WHO/MHRA for Clinical samples.
- Capable of handling 3-4 members team to oversee MD/MV/sample analysis.
- Expert in all extraction techniques solid phase extraction (SPE), Derivatization, liquid-liquid extraction and protein precipitation of molecules from various matrices like plasma/urine/blood and ready to perform bench work.
- During Project sample analysis and Method Validation evaluator of traceable documentation and SOP driven GLP system, also will be responsible for tractability of generated data and responses to QA finding.
- Capability to handle of instrumentation troubleshooting and its malfunction, experimental designing skills to resolve day2day troubles.
- Prepare and review method SOPs, Draft SOPs, System SOPs.
Research Scientist
Lambda Therapeutic Research LTD
Ahmedabad, Gujarat
07.2009 - 06.2016
- Handled various makes of LC-MS/MS system like: APISciex-4000 &3200, Waters, Shimadzu-8060 etc.
- Involvement in method Development of drug molecules and its metabolites using LC-MS/MS.
- Method Validation for developed methods as per international regulatory guidelines like: US-FDA, TGA, ANVISA, EMEA etc.
- Study sample analysis of biological samples for BA/BE studies and various Pharmacokinetic studies.
- Ensure about GLP implementation in laboratory and faced GLP audits from various regulatory authorities like USFDA/ENVISA/WHO/MHRA for Clinical samples.
- Expert in all extraction techniques solid phase extraction (SPE), Derivatization, liquid-liquid extraction and protein precipitation of molecules from various matrices like plasma/urine/blood and ready to perform bench work.
- During Project sample analysis and Method Validation evaluator of traceable documentation and SOP driven GLP system, also will be responsible for tractability of generated data and responses to QA finding.
- Capability to handle of instrumentation troubleshooting and its malfunction, experimental designing skills to resolve day2day troubles.
- Prepare and review method SOPs, Draft SOPs, System SOPs.
Research Coordinator
Lambda Therapeutic Research Ltd.
Ahmedabad, Gujarat
02.2004 - 04.2009
- Freezer room handling and its related activities.
- Responsible for Calibration of deep freezer and hot spot determination.
- Study sample retrieval and its storage, Arrangement of free space in freezer for upcoming study samples.
- Responsible for checking of freezer temperature data.
- Responsible for disposal of study sample, MV sample and taking the approval from the sponsor.
- Study sample separation and its final storage to the deep freezer.
- Responsible for sores operation and chemical procurement according to project demand.
- Responsible to maintain store material inventory.
- Responsible for Maintain column inventory.
Education
Bachelor of Science - Chemistry
K.K. Shah Jarodwala Maninagar Science College
Ahmedabad 06.2000 - 07.2003
Master of Science - Industrial Chemistry
Sir P. P. Institute of Science
Bhavnagar University 08.2007 - 09.2009
Skills
Logistical Planning
Decision Making
Team Bonding
Technical Support
Fluent in [Hindi, Gujarati, English]
Project Management
Timeline
Project Leader
Cliantha Research
07.2020 - Current
Manager
Cliantha Research
07.2016 - 06.2020
Research Scientist
Lambda Therapeutic Research LTD
07.2009 - 06.2016
Master of Science - Industrial Chemistry
Sir P. P. Institute of Science
08.2007 - 09.2009
Research Coordinator
Lambda Therapeutic Research Ltd.
02.2004 - 04.2009
Bachelor of Science - Chemistry
K.K. Shah Jarodwala Maninagar Science College
06.2000 - 07.2003