JAIMIN PATEL
Assistant Manager-ADL
178, Navo vas, Village:Majra, Taluko:Prantij
Summary
Accomplished Assistant manager with over 8+ years of experience specializing in ADL method development for various pharmaceutical formulations, including solid oral, liquid oral, and parenteral products. Proficient in conducting literature reviews, method development, partial method validation, forced degradation, method optimization, and stability testing. Demonstrated expertise in maintaining analytical instruments and leading experimental programs for timely project completion.
Overview
8
8
years of professional experience
5
5
Certifications
3
3
Languages
Work History
Assistant Manager
Senores Pharmaceuticals Limited
06.2026 - Current
- Conducted comprehensive literature reviews and scientific research to support analytical development projects.
- Performed analysis of innovator products, development batches, and stability study samples using validated analytical techniques.
- Developed, optimized, and validated analytical methods for drug products in accordance with ICH Q14 (Analytical Procedure Development) and ICH Q2(R2) guidelines.
- Prepared and reviewed Method Development Reports (MDR), Method Validation Reports (MVR), and Methods of Analysis (MOA) in compliance with regulatory and quality requirements.
- Managed calibration, qualification, maintenance, and troubleshooting of analytical instruments, ensuring laboratory readiness and data integrity.
- Supported analytical method transfer activities and critical studies at manufacturing facilities and external contract testing laboratories.
- Ensured adherence to Good Laboratory Practices (GLP), data integrity standards, and laboratory quality systems.
- Trained and mentored junior scientists and laboratory personnel on analytical techniques, instrument operation, and laboratory best practices.
- Collaborated with cross-functional teams including Formulation & Development (F&D), Quality Assurance (QA), Regulatory Affairs (RA), and Manufacturing to support pharmaceutical product development and lifecycle management.
Senior Research Fellow
Emcure Pharmaceuticals Limited
04.2024 - 06.2026
- Conducted literature review and supported development of analytical methods for pharmaceutical formulations in Analytical Development Laboratory (ADL).
- Developed and optimized analytical methods for Assay, Related Substances, and Dissolution testing.
- Performed method development activities including solubility studies, forced degradation studies, and reference standard characterization.
- Designed and executed experimental plans for analytical method development and optimization studies.
- Conducted analytical testing to support product development and stability studies.
- Prepared analytical documentation including test methods, validation protocols, validation reports, and development reports.
- Supported analytical method transfer activities from R&D/ADL to QC and other laboratories.
Team Leader
Novamis Pvt. Ltd. T/A Orbit Pharma
07.2023 - 04.2024
- Conducted literature review and Design of Experiments (DoE) for analytical method development.
- Developed and optimized methods for Assay, Related Substances (RS), and Dissolution studies.
- Planned experiments, scheduled activities, and ensured timely completion of project milestones.
- Performed stability study monitoring and data trend analysis.
- Managed laboratory inventory including solvents, columns, standards, and reference listed drugs.
- Performed root cause analysis and resolved analytical and instrumental issues through troubleshooting.
- Reviewed technical documents including STPs, specifications, validation protocols/reports, and development reports.
- Supported analytical method transfer activities ensuring compliance and cross-functional coordination.
Senior Executive
Cadila Pharmaceutical Ltd.
07.2022 - 07.2023
- Developed methods for Assay, RS and Dissolution Development, and prepared Development Reports.
- Conducted forced degradation studies and performed routine analysis of stability samples.
- Characterized the Reference Product and analyzed it according to specifications.
- Conducted Multimedia Dissolution testing and prepared the corresponding CDP Report.
- Ensured Regulatory compliance in all processes and documentation.
- Collaborated with team members to enhance Collaboration and communication within the department.
Research Associate
Intas Pharmaceutical Ltd.
07.2020 - 07.2022
- Developed analytical methods for Assay, Related Substances (RS), and Dissolution; prepared development reports.
- Conducted forced degradation studies and routine stability sample analysis.
- Performed reference product characterization and ensured compliance with specifications.
- Executed multimedia dissolution testing and generated CDP reports.
- Managed laboratory inventory including solvents, columns, standards, and reference listed drugs.
- Ensured regulatory compliance in all analytical processes and documentation.
- Performed data analysis and interpretation to support result evaluation and decision-making.
- Applied troubleshooting and problem-solving to resolve analytical and technical issues.
Research Associate
Veeda Clinical Research Pvt. Ltd
06.2018 - 06.2020
- Develop and validate Analytical Method Validation bioanalytical methods using LC-MS/MS, HPLC, and other analytical techniques for the quantification of drugs and metabolites in biological samples.
- Maintain and troubleshoot analytical instrumentation, ensuring proper operation and performance.
- Performed sample analysis and interpreted data to support research outcomes.
Education
Master's M. Pharm - Quality Assurance
Saraswati Institute of Pharmaceutical Sciences
Gandhinagar, India04.2018
Bachelor's Pharmacy -
Saraswati Institute of Pharmaceutical Sciences
Gandhinagar, India04.2016
H.S.C - Biological Sciences (Biology)
P.M. Patel Sarvajanik Vidyalay
Gandhinagar, India05.2012
S.S.C - science
Shri Bhairavnath Vidhyalay
Sabarkantha05.2010
Skills
Documentation
Innovative problem-solving
Certification
Research Article entitled Stability indicating RP-HPLC method development and validation for simultaneous estimation of Sofosbuvir and Velpatasvir in tablet dosage form, World Journal of Pharmacy and Pharmaceutical Sciences, Volume 7, Issue 5, 813-828
Timeline
Assistant Manager
Senores Pharmaceuticals Limited
06.2026 - Current
Senior Research Fellow
Emcure Pharmaceuticals Limited
04.2024 - 06.2026
Team Leader
Novamis Pvt. Ltd. T/A Orbit Pharma
07.2023 - 04.2024
Front Runner Award for performing with excellence during performance of the work in the year 2023, Cadila Pharmaceutical Ltd.
04-2023
Well Done work Award during performance of the work in the year 2022, Cadila Pharmaceutical Ltd.
12-2022
Senior Executive
Cadila Pharmaceutical Ltd.
07.2022 - 07.2023
Research Associate
Intas Pharmaceutical Ltd.
07.2020 - 07.2022
Excellence Award during performance of the work in the Quarter-IV for the year 2019,Veeda Clinical Research Pvt Ltd.
12-2019
Research Associate
Veeda Clinical Research Pvt. Ltd
06.2018 - 06.2020
Secured 1st position in M.Pharm, Quality Assurance specialization, Saraswati Institute of Pharmaceutical Science, Gandhinagar
05-2018
Research Article entitled Stability indicating RP-HPLC method development and validation for simultaneous estimation of Sofosbuvir and Velpatasvir in tablet dosage form, World Journal of Pharmacy and Pharmaceutical Sciences, Volume 7, Issue 5, 813-828
04-2018
Master's M. Pharm - Quality Assurance
Saraswati Institute of Pharmaceutical Sciences
Bachelor's Pharmacy -
Saraswati Institute of Pharmaceutical Sciences
H.S.C - Biological Sciences (Biology)
P.M. Patel Sarvajanik Vidyalay
S.S.C - science
Shri Bhairavnath Vidhyalay