PAWAN KUMAR
Panchkula
Summary
Highly motivated and results-driven professional seeking opportunities in Analytical Research & Development (AR&D) within the Pharmaceutical Industry. With over 8.5 years of hands-on experience in analysis, I bring a meticulous and analytical approach to work. An adaptive team player with in-depth knowledge of data collection, confidential document control, and problem-solving. Eager to contribute expertise and drive innovation within a growth-oriented organization.
Overview
9
9
years of professional experience
Work History
Research Associate
Pure & Cure Healthcare Private Limited
07.2022 - Current
- Having a sound knowledge of chromatographic analysis such as Tailing Factor, Resolution, Peak Purity, Purity Angle, Purity Threshold, Capacity Factor, Theoretical Plates and Signal to Noise Ratio
- Analytical method development/optimization for organic impurities, assay, content (minor components) of cephalosporin drugs & non-cephalosporin drugs (API, Intermediate & RM/KSM) by HPLC.
- Analytical method development of GTI and cohort of concerned impurities (Nitrosoamine impurities) using HPLC & LCMS.
- Analytical method development for elemental impurities & metal content (minor components) of API by ICPMS & AAS.
- To perform analytical method transfer to other manufacturing site.
- To perform forced degradation study of drug substance.
- To perform analytical method validation by HPLC, AAS, LCMS & ICPMS.
- To identify the root cause and provide technical input for the OOS/OOT observed in the plant during regular analysis/stability study analysis and proposal of CAPA for the same.
- To prepare analytical method validation protocols, reports.
- To determine the physiochemical properties of an API by HPLC such as partition coefficient (LogP), equilibrium solubility (for drug classification) & dissociation constant etc and prepare technical report for the same.
- To identify the unknown impurities by using LCMS during troubleshoot of plant samples, stability study & forced degradation study.
- To prepare analytical method development reports (MDR) and validation protocols, excels & reports.
- Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns.
- Kept abreast of current industry, scientific and regulatory developments and issues.
Research Associate-II
Ind-Swift Laboratories Limited
07.2021 - 06.2022
- Analytical method validation for related substances, assay & content of impurities (e.g. GTI & non-GTI) by HPLC.
- Analytical method validation for chromatographic purity & residual solvents by GC.
- Helped team meet regulatory requirements by coordinating documentation and filings.
- Troubleshoot and resolved equipment and analytical method issues.
- Operated and performed calibration on laboratory equipment and instruments (e.g. HPLC, GC, Analytical weighing balance & pH meter).
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
- Prepared analytical method validation protocols & reports.
- Maintained laboratory logbook update for online review.
Officer
Saurav Chemicals Limited
11.2018 - 07.2021
- Routine analysis including Assay, RS, Purity, WS qualifications, Particle size distribution & stability study.
- Experienced in preparation and execution of analytical method validation protocols and reports.
- Performed analytical method validations & tech transfer by HPLC.
- Performed analytical method development & validation by particle size distribution and ICPMS.
- Experienced in forced degradation study via mass balance technique.
- Experienced in method development and validation on ICPMS for EI's as per ICH Q3D guideline and USP general chapter & .
Executive
Panacea Biotec Limited
02.2018 - 11.2018
- Performed working standard/In house reference standard qualifications.
- Performed content uniformity, dissolution & disintegration time testing for drug products.
- Performed routine assay, related substances, chromatographic purity & compatibility study for the drug product.
- Performed analytical method optimization and validation by HPLC for DP.
- Maintaining laboratory notebook as per the FDA Regulation and cGMP Requirement.
Sr. Chemist
Nectar Lifesciences Limited
10.2016 - 02.2018
- Prepared reagents and solutions following standard laboratory formulas and procedures.
- Ordered, calibrated, troubleshoot and maintained laboratory equipment in good working order.
- Developed and validated wet analysis methods of new chemical entities & API molecules.
- Performed routine wet analysis such as description, appearance of solution/color of solution, identification test (chemical), water/moisture content by KF autotitrator, Assay by Titration & by UV/VIS Spectrophotometer, IR testing by FTIR, LOD, ROI, Heavy metal test and stability testing etc.
- Calibration of analytical weighing balance, UV/Vis spectrophotometer, Karl Fisher, FT-IR, Auto-titrator, pH Meter, Melting Point & Polarimeter.
Education
M.Sc. - Organic Chemistry
Maharishi Markandeshwar University
01.2016
B.Sc. - Non-Medical
Govt. College
01.2013
12th - Non-Medical
HBSE
01.2010
10th - undefined
HBSE
01.2008
Skills
- Comprehensive literature reviews
- Laboratory management
- Data research and analysis
- Laboratory techniques
- Technical report writing
- Quantitative and qualitative research methods
- Data insight generation
- Safety compliance in lab environments
- Excellent attention to detail
Languages
English
Hindi
Punjabi
Attributes
- Positive Thinking
- Creative
- Smart work
- Ability to work under pressure
- Optimistic
- Targeted Approach
Key Deliverables
- WET Method Development of New Chemical Entities & API Molecules.
- Routine WET analysis including stability.
- WET Analysis including Assay by Titration & by UV/VIS Spectrophotometer.
- Calibration of Weighing Balance, UV, Karl Fisher, FT-IR, Auto-titrator, pH Meter, Melting Point & Polarimeter.
- Calibration of HPLC.
- Routine analysis including Assay, RS, Purity, Compatibility study, WS qualifications, Particle size.
- IR analysis.
- UV analysis.
- Experience in forced degradation study via mass balance technique.
- Experience with method development and validation on ICPMS as per ICHQ3D and USP general chapter 232, 233.
- Experience in preparation and execution of analytical method validation protocol and report.
- Currently working in HPLC and GC validation section.
Instrumentation
- Karl Fisher, Kafi, Lab-India
- Karl Fisher, Titrando 836, Metrohm
- Melting Point, Labindia MR Vis.
- Infrared Spectrophotometer, Spectrum100, Perkin Elmer
- UV Spectrophotometer, Lambda35, Perkin Elmer
- Auto-titration, 905 titrando, Metrohm
- Polarimeter, Autopol V, Rudolph
- HPLC, Waters, alliance
- HPLC, Agilent, 1100 series
- HPLC, Shimadzu, 2010
- Dissolution, Electrolab, EDT 08lx
- Disintegration Tester, Electrolab, ED-2AL
- ICPMS, Agilent, 7800 series with ECM server
Disclaimer
I solemnly declare that the details mentioned above are correct to the best of my knowledge and belief.
Personal Information
- Location Preference: Anywhere in India
- Father's Name: Sh. Satpal Singh
- Date of Birth: 11/13/91
- Gender: Male
- Marital Status: Single
Timeline
Research Associate
Pure & Cure Healthcare Private Limited
07.2022 - Current
Research Associate-II
Ind-Swift Laboratories Limited
07.2021 - 06.2022
Officer
Saurav Chemicals Limited
11.2018 - 07.2021
Executive
Panacea Biotec Limited
02.2018 - 11.2018
Sr. Chemist
Nectar Lifesciences Limited
10.2016 - 02.2018
B.Sc. - Non-Medical
Govt. College
12th - Non-Medical
HBSE
10th - undefined
HBSE
M.Sc. - Organic Chemistry
Maharishi Markandeshwar University
Similar Profiles
Pranshu MUTREJAPranshu MUTREJA
Production Engineer at Pure wax Private LimitedProduction Engineer at Pure wax Private Limited
Nitesh Kumar SenNitesh Kumar Sen
Officer-Quality Assurance (Vendor Management) at Puniska Healthcare Private Limited (Subsidiary of Amneal Pharmaceutical Private Limited)Officer-Quality Assurance (Vendor Management) at Puniska Healthcare Private Limited (Subsidiary of Amneal Pharmaceutical Private Limited)
Siddharth KaushikSiddharth Kaushik
Sales Manager at Siemens Healthcare Private LimitedSales Manager at Siemens Healthcare Private Limited