Madhuri Jadhav
Kharghar
Summary
Analytical development professional with 9 years of experience in pharmaceuticals, specializing in API and formulation. Currently leads a high-performance team in reverse engineering method development and validation, ensuring compliance with US FDA, ICH, and GMP guidelines. Proven success in managing client communications and achieving favorable outcomes in regulatory audits. Expertise in project planning and execution for regulated markets, driving timely project delivery.
Overview
11
11
years of professional experience
Work History
Team Leader - ADL
Theta Beta Analogarithms
Navi Mumbai, India
08.2024 - Current
- Leading a high-performance team in project planning and execution for regulated markets.
- Driving Reverse Engineering studies (excipient profiling and grade identification).
- Managing client communications and ensuring project delivery within strict timelines.
Research Officer
Glenmark Pharmaceuticals
Navi Mumbai, India
11.2023 - 06.2024
- Contributed to oncology drug development and submission-level documentation.
- Executed complex method development and validation for NCEs.
- Conducted characterization studies using FTIR, NMR, XRD, etc., and prepared detailed reports.
Scientist-II - ADL
Theta Beta Analogarithms
Navi Mumbai, India
10.2021 - 05.2023
- Developed validated methods for API and drug products; handled forced degradation.
- Performed method development and validation using Gas Chromatography (GC).
- Driving Reverse Engineering studies (Excipient profiling & grade identification).
Senior Analytical Chemist (Reviewer)
Anicare Pharmaceuticals Pvt. Ltd.
Navi Mumbai, India
02.2021 - 10.2021
- Reviewed validation protocols and reports, and ensured 100% data integrity.
Executive Analytical Chemist
Kores India Ltd.
Mumbai, India
04.2016 - 02.2021
- Conducted routine stability studies, calibrations, and advanced analytical testing.
- Performed method development and validation using HPLC and GC techniques.
- Reviewed plant documentation and supported technology transfer activities at the manufacturing site.
Junior Analytical Chemist
Promas Research Laboratories
Navi Mumbai, India
10.2015 - 04.2016
- Performed routine calibration and maintenance of analytical instruments to guarantee accurate results.
- Managed inventory of chemicals and reagents, ensuring availability for all scheduled tests.
- Analysed raw materials, intermediates, and finished products to comply with regulatory requirements.
- Utilised High Performance Liquid Chromatography HPLC for separation, identification, and quantification of compounds.
Education
M.Sc. - In-Organic Chemistry
K.V. Pendharkar college Dombivli (E)
Dombivli, (E)12-2015
B.Sc. - Chemistry
K.V. Pendharkar college Dombivli (E)
Dombivli, (E)04-2013
H.S.C. -
Tilak Nagar Vidyamandir Dombivli (E)
Dombivli, E03-2010
S.S.C. -
Vividhalakshi Vidyalaya
03-2008
Skills
- Method Development & Validation
- Impurity Profiling
- OOS/OOT Investigations
- Tech Transfer
- Cleaning Validation
- USFDA
- NABL
- GMP
- Good Documentation Practices
- Regulatory compliance
- Method validation
- Analytical techniques
- Team supervision
- Risk assessment
- Client communications
- Project management
- Problem solving
- Data integrity
- Team building
- Time management
- Leadership skills
Languages
English
Marathi
Hindi
Roles And Responsibilities
- Analysis of Raw Materials, Intermediate and Finished Product of API & Formulation as per SOP & GMP in HPLC & GC & other analytical instruments.
- Performing Stability analysis of products and their records.
- Calibration of Instruments like HPLC, GC, Melting Point, IR, UV, Auto titrator, Balance.
- Perform wet lab analysis of raw material, Intermediate & finished product.
- Preparing bench reagent and keep their records.
- Preparing volumetric solutions their standardization and documentation.
- Preparation of Certificate of Analysis.
- Preparing working standard & their analysis.
- Monitoring control sample record.
- Recording the daily temp. & Humidity of different room in laboratory.
- Maintaining log books & other Documents.
- Excipient quantification by GPC with RI detector.
- NIR (Near-infrared spectroscopy)
Custom Section
- NABL
- USFDA
- CLIENT AUDIT
Instruments Used
- HPLC (Waters 2695) & Shimadzu Prominence
- Dissolution Apparatus (Lab India)
- Gas Chromatography (PerkinElmer Clarus 500, Netel India Ltd)
- FTIR (Infra-red spectroscopy)- (Thermo Fischer Scientific)
- PH & Conductivity Meter- (Lab India)
- Karl Fischer Apparatus- (Lab India)
- Auto titrator- (Lab India)
- UV spectrophotometer-(JASCO-V530)
- Particle Size Analyzer- (Malvern Wet & Dry)
- ICP-OES – (Thermo Fischer Scientific)
- Gel Permeable chromatography with RI detector
- NIR (Near infrared spectroscopy)
- Liquid chromatography Mass Spectrometer (Agilent)
- UHPLC (Agilent)
- NMR Spectroscopy (Bruker)
Hobbies and Interests
Reading
Disclaimer
I hereby declare that all the above information furnished about me is true to the best of my knowledge and belief.
Timeline
Team Leader - ADL
Theta Beta Analogarithms
08.2024 - Current
Research Officer
Glenmark Pharmaceuticals
11.2023 - 06.2024
Scientist-II - ADL
Theta Beta Analogarithms
10.2021 - 05.2023
Senior Analytical Chemist (Reviewer)
Anicare Pharmaceuticals Pvt. Ltd.
02.2021 - 10.2021
Executive Analytical Chemist
Kores India Ltd.
04.2016 - 02.2021
Junior Analytical Chemist
Promas Research Laboratories
10.2015 - 04.2016
M.Sc. - In-Organic Chemistry
K.V. Pendharkar college Dombivli (E)
B.Sc. - Chemistry
K.V. Pendharkar college Dombivli (E)
H.S.C. -
Tilak Nagar Vidyamandir Dombivli (E)
S.S.C. -
Vividhalakshi Vidyalaya