Nirav Hareshchandra Soni
Vadodara,Gujarat, India
Summary
Expert in analytical and data analysis for complex injectable formulations, including microspheres, liposomes, and inhalation suspensions as well as Complex transdermal products like narcotics patch formulation and complex Transdermal formulations. Proven track record in executing feasibility evaluations, method development, and pre-validation activities, along with writing validation protocols and technical documents. Extensive experience in chromatography technologies and data interpretation, ensuring compliance with regulatory guidelines. Strong leadership in analytical method development for drug substance testing and successful coordination of method transfer and validation across departments. Responsible Manager, passionate about delivering outstanding quality and service. Offering 18 years of experience in industry with a history of recognition for performance.
Overview
1
1
Certification
19
19
years of professional experience
Work History
Manager- Analytical Development (Complex Injectable Formulation)
Sun Pharmaceutical Industries Limited
Vadodara, Gujarat, India
02.2020 - Current
- Analytical Method Development, validation and plant side troubleshoot for Complex long acting Injectable formulations ( Depot and liposomal products) , sustained released transdermal and patch products.
- Gained practical experience in handling narcotics and anticancer products.
- Development and validation of various analytical methods like, Assay, Related substance, and various characterisation test for Polymer Based Injectable nano suspension products.
- Impurity profiling and impurity query response for USFDA /EU observation and orthogonal method development and submission.
- Method development and Validation for Residual Solvent test for variety of non-oral products.
- Worked extensively on Particle Size Distribution using Mastersizer and zetasizer instruments.
- Conducted Reverse Engineering to identify and quantify different excipients in various RLDs for ANDA and NDA application.
- Provided critical support to Central Analytical laboratory for stability studies and facilitated technology transfer to plant location.
- Performed analysis and Calculated Molecular Weight by GPC for Polymer Based Microspheres and Residual Solvent using GC
- Method development and Validation for particle size analysis of drug product by Malvern Mastersizer 3000.
- Used techniques like Ion Chromatography, HPLC with ELSD Detector and RI Detector.
- Impurity profiling of Complex Microsphere products and Aerosol Products using HRMS (High Resolution Mass Spectrometry).
- Engaged in preclinical and clinical studies focused on BA/BE studies and data evaluation.
- Developed and delivered comprehensive training programmes, improving team skills and performance.
- Managed inventory control to maintain optimal stock levels and minimise waste.
- Monitored staff performance and implemented targeted improvement plans.
- Supported employee morale and well-being by developing positive practices centred on career development and individual job satisfaction.
- Cultivated work environment focused on personal responsibility, continuous improvement and delivering high-quality results.
- Advised senior management on facilities needs and delivered ongoing operational support.
- Supervised supply purchases, management and tracking in line with budgetary requirements.
- Optimised workforce scheduling, balancing team workload to prevent burnout and maintain morale.
Research Executive - Analytical Development (Complex Injectable Formulation R&D)
Sun Pharma Advanced Research Company Limited
Vadodara
01.2014 - 03.2020
- Managed analytical R&D projects for development of drug substances and drug products, ensuring alignment with project goals.
- Method development and Validation for Assay, Dissolution and Related Substances of Complex Injectables (Injectable Suspension).
- Aerodynamic particle size distribution (APSD) by using next generation impactor (NGI).
- Conducted zeta-potential measurements using a Zetasizer to assess particle stability.
- Particle size analysis of drug product by Malvern Mastersizer 3000.
- USP analytical Method Verification.
- Stability studies of drug product.
- Calibrated and maintained analytical instruments to ensure accurate and reliable testing results.
- Executed pre-clinical animal studies for pre-formulation and finished products, assessing efficacy of various derma products, ophthalmic suspensions, liposomal products, and long-acting microsphere injectables using LC-MS/MS techniques.
Research Assistant – Analytical development (ADD-NDDS)
Sun Pharmaceutical Industries Limited
Vadodara
12.2008 - 12.2013
- Managed analytical R&D projects for development of drug substance and drug product, ensuring alignment with regulatory standards.
- Developed and validated methods for assay, dissolution, and related substances of complex injectables, enhancing analytical reliability.
- Aerodynamic particle size distribution (APSD) by using next generation impactor (NGI).
- Conducted zeta-potential analysis using Zetasizer to assess drug formulation characteristics, contributing to formulation optimisation.
- Particle size analysis of drug product by Malvern Mastersizer 3000.
- USP analytical Method Verification.
- Stability studies of drug product.
- Performed regular calibration and maintenance of analytical instruments for optimal performance.
- Execution of pre-clinical animal studies for pre-formulation and finished product to check the efficacy of various Derma products, Ophthalmic suspension, Liposomal products and Long-Acting Microsphere Injectable using LC-MS/MS.
Research Associate
Lambda therapeutic Research Limited
Ahmedabad, Gujarat
02.2007 - 12.2008
- Method Development and Method Validation for Pharmacokinetic BA/BE studies using LC-MS/MS.
- Taken part in separation of Biological fluids from blood and timepoints collection of various Pharmacokinetic studies.
- Laboratory maintenance and calibration of various analytical instruments like pH meter, Micro balance and Analytical balance, Micro pipettes.
- Routine BA/BE studies’ sample analysis using HPLC and LC-MS/MS.
- Undergone various extraction techniques to facilitate sample cleanup and detection of the same.
- Worked in strict GLP environment and upkept the Instrument and documentation up to the mark without any observation.
- Identified and resolved issues during routine analysis, performing basic troubleshooting of HPLC and LC-MS/MS.
- Coordinated with Senior Scientist to ensure timely completion of projects.
Education
M. Sc. - Industrial Chemistry
S P University
Anand, Gujarat01-2007
B.Sc. - Industrial Chemistry
S P University
Anand, Gujarat01-2005
Skills
- Complex Injectable Formulation
- Analytical Method Development
- Bioanalytical Method Development
- Validation of Analytical and Bio-Analytical methods
- HRMS Impurity profiling and data interpretation
- Validations & Technology Transfers
- Effective communication
- Regulatory requirements understanding
- Decision making
- Knowledge of regulatory standards
- Technical documentation
- SOPs Preparation
- Malvern mastersizer 3000 & Zetasizer
- TOF, Ion trap quadrapole LCMSMS (HRMS)
- Viscosity determination by Viscometer (Anton paar and Brookfield)
- Signal Electron Microscope (SEM)
- Data Analysis
- Cross-functional Coordination
- Team Management & Leadership
- Training program development
- Presentation skills
- Good Listener
- Query Response
- Team Lead capabilities
- Leadership skills
- Stability studies
- Project management
- Cross-functional collaboration
- Inspiring motivation
- Product development
- Mentoring and coaching
- Take active part in submission and approval of following formulations
1) Submission of Leurolide and Octreotide Depot Injections as well as Sonidegib & Bupivacian Liposomal injection
2) Sucessful approval for Doxorubicine Liposomal Injection
3) Submission of Paliperidone long acting injection
Languages
English
Hindi
Gujarati
Websites, Portfolios and Profiles
https://www.linkedin.com/in/nirav-soni-5457901b
References
Mr. Ankit Patel, Senior Manager (Injectables Microspheres), Sun Pharmaceutical industries Limited, R&D, Vadodara, Gujarat, India, 6351945386
Certification
- Lipidomics certified for two day training
Interests
- Cooking and painting
Timeline
Manager- Analytical Development (Complex Injectable Formulation)
Sun Pharmaceutical Industries Limited
02.2020 - Current
Research Executive - Analytical Development (Complex Injectable Formulation R&D)
Sun Pharma Advanced Research Company Limited
01.2014 - 03.2020
Research Assistant – Analytical development (ADD-NDDS)
Sun Pharmaceutical Industries Limited
12.2008 - 12.2013
Research Associate
Lambda therapeutic Research Limited
02.2007 - 12.2008
M. Sc. - Industrial Chemistry
S P University
B.Sc. - Industrial Chemistry
S P University