Open To Work
Jaydeep Joshi
Mumbai
Summary
Analytical & Regulatory Research Scientist with 15+ years of experience in pharmaceutical Analytical R&D. Currently serving as Assistant Manager – Analytical Research (LC-MS/MS) with strong specialization in trace-level analysis of Nitrosamine's and NDSRI impurities in APIs and finished dosage forms.
Highly experienced in LC-MS/MS method development, validation, impurity profiling, and regulatory risk assessment aligned with ICH M7 requirements. Proficient in in-silico toxicology tools (Derek Nexus & Sarah Nexus) for scientifically justified, regulator-acceptable genotoxic impurity evaluations. Proven track record of supporting global regulatory audits and ensuring data integrity and compliance.
Overview
15
15
years of professional experience
Work History
Assistant Manager
IPCA Laboratories Limited
Mumbai
09.2022 - Current
- Lead LC-MS/MS–based trace-level (ppb/ng) analysis of Nitrosamines and NDSRIs in APIs and finished dosage forms
- Successfully developed and validated more than 120 LC-MS/MS methods for Nitrosamines and NDSRIs across diverse APIs and finished pharmaceutical products
- Develop, optimize, and validate highly sensitive and selective LC-MS/MS methods in alignment with ICH M7, FDA, EMA, and global regulatory expectations
- Perform end-to-end impurity risk assessment, evaluation, and lifecycle management for Nitrosamines and NDSRIs
- Support impurity qualification using in-silico toxicology tools such as DEREK Nexus and Sarah Nexus for scientifically justified regulatory decisions
- Interpret complex LC-MS/MS datasets for impurity identification, structural confirmation, and accurate quantification
- Prepare comprehensive analytical reports, impurity risk assessments, and regulatory response documentation
- Provide plant and manufacturing support, including LC-MS/MS troubleshooting (method sensitivity, selectivity, system suitability, performance optimization)
- Support global regulatory inspections and audits including USFDA, WHO, MHRA, TGA, ANVISA, and internal QA audits
- Ensure strict compliance with GLP, GDP, GMP, change control, deviation management, and data integrity requirements
Assistant Manager
Deepak Nitrite Limited
Vadodara
02.2021 - 09.2022
- Established and operationalized a new LC-MS/MS analytical development laboratory to support chemical process R&D and manufacturing
- Led installation, commissioning, and performance verification of triple quadrupole LC-MS/MS instruments
- Conducted instrument performance checks and challenge testing suitable for a non-GLP chemical R&D environment
- Developed and implemented internal SOPs for instrument operation, maintenance, calibration checks, and data handling
- Provided routine LC-MS/MS analytical support for nitrite and other low-molecular-weight chemical compounds
- Developed and optimized LC-MS/MS methods for low-MW, non-chromophoric compounds not amenable to UV detection
Assistant Manager
Cadila Pharmaceuticals Limited
Ahmedabad
02.2019 - 02.2021
- Led a Method Development cluster of more than 10 members
- Executed analytical method development and routine testing, including:Related substances / impurities
Organic Volatile Impurities (OVI)
Assay, moisture, IR, UV - Transferred validated methods to Quality Control (QC) with complete documentation and analyst training
- Planned daily analytical activities, sample tracking, and controlled destruction
- Managed change controls, deviations, incidents, and laboratory notebooks
Assistant Manager
Elixir Pharma
Ahmedabad
04.2018 - 02.2019
- Developed and qualified analytical methodologies for product characterization, release, and stability testing in compliance with regulatory expectations
- Performed routine analytical testing
- Prepared and reviewed SOPs, MOAs, method validation protocols, and reports
- Planned daily analytical workload, sample distribution, and sample disposal
- Maintained laboratory notebooks, deviations, change controls, and incident records
Senior Officer
Concord Biotech Limited
Ahmedabad
11.2016 - 04.2018
- Performed analytical method development and routine analysis for APIs and formulations, including: Related substances, dissolution testing Assay, blend uniformity, Excipient compatibility
- Operated, maintained, and calibrated HPLC systems as per approved SOPs
Senior Research Associate
Piramal Enterprises Limited
Ahmedabad
05.2015 - 11.2016
- Developed ultra-fast UPLC–MS methods (single quadrupole LC-MS) with short run times to meet aggressive turnaround time (TAT < 45 minutes) requirements
- Performed rapid analysis of reaction mass samples from synthesis teams using optimized UPLC–MS methods
Research Associate
Lambda Therapeutic Research Limited
Ahmedabad
11.2010 - 05.2015
- Developed and validated selective and sensitive LC-MS/MS bioanalytical methods for quantitative determination of drugs and metabolites in biological matrices using appropriate extraction techniques
- Performed Bioavailability (BA) / Bioequivalence (BE) study sample analysis in compliance with applicable regulatory requirements
Education
Master of Science -
K.K. Shah Jarodwala Maninagar Science College
Gujarat University, Ahmedabad01-2010
Bachelor of Science -
K.K. Shah Jarodwala Maninagar Science College
Gujarat University, Ahmedabad01-2008
Skills
- LC-MS/MS Analysis of Nitrosamine's & NDSRIs
- Genotoxic Impurity (GTI) Evaluation & ICH M7 Risk Assessment
- In-Silico Toxicology (Derek Nexus & Sarah Nexus)
- Analytical Method Development & Validation
- Impurity Profiling & Structural Elucidation
- Stability Studies & Forced Degradation
- Regulatory Documentation & Inspection Support
- GLP, GDP, GMP & Data Integrity Compliance
INSTRUMENTATION EXPERTISE
- LC-MS/MS (Triple Quadrupole): Sciex, Waters, Shimadzu, Thermo, Agilent
- UPLC & HPLC Systems
- Gas Chromatography (GC) with Headspace Sampler
- UV–Visible Spectrophotometer
- Karl Fischer Titrator (Metrohm)
- Dissolution Apparatus
SOFTWARE & DATA SYSTEMS
- MassLynx | QuanLynx
- Empower
- LC-Quan
- Lab Solutions | LC Solutions
- SCIEX OS | Analyst
- Chromeleon
- Derek Nexus | Sarah Nexus
TRAINING & WORKSHOPS
Advanced Workshop on Analysis of Nitrosamine Impurities using Mass Spectrometry
Conducted by Spinco, Chennai | September 2025
- Focused on LC-MS/MS–based detection, quantification, method optimization, and regulatory expectations for nitrosamine impurities
Annual Scientific User Meeting (MultiCASE)
Organized by MultiCASE, Ahmedabad | April 2025
- Gained insights into nitrosamines, in-silico toxicology, QSAR models, CPCA, and Ames interpretation
- Enhanced understanding of ICH M7 risk assessment and global regulatory expectations
- Participated in expert panel discussions covering real-world applications, regulatory FAQs, and industry case studies
PAQ Forum on Handling Nitrosamines & NDSRIs in Pharmaceuticals
Organized by Glostem, Ahmedabad | October 2023
- Covered regulatory updates, ICH M7 expectations, risk assessment strategies, acceptable intake (AI) justification, and mitigation approaches for nitrosamines and NDSRIs
Work Preference
Job Search Status
Open to workWork Type
Full TimeLocation Preference
On-SiteSalary Range
₹45000/yr - ₹200000/yrTimeline
Assistant Manager
IPCA Laboratories Limited
09.2022 - Current
Assistant Manager
Deepak Nitrite Limited
02.2021 - 09.2022
Assistant Manager
Cadila Pharmaceuticals Limited
02.2019 - 02.2021
Assistant Manager
Elixir Pharma
04.2018 - 02.2019
Senior Officer
Concord Biotech Limited
11.2016 - 04.2018
Senior Research Associate
Piramal Enterprises Limited
05.2015 - 11.2016
Research Associate
Lambda Therapeutic Research Limited
11.2010 - 05.2015
Master of Science -
K.K. Shah Jarodwala Maninagar Science College
Bachelor of Science -
K.K. Shah Jarodwala Maninagar Science College