Proficient Analytical Scientist with over 6 years of experience in analytical and bioanalytical sample analysis, document review. Bio-Analytical sample analysis (Urine, Plasma, Tissue). Analytical Method Development & Validation (Tablets, Capsules, suspensions, solutions, PFOS). Analytical Sample Analysis (Raw materials, in process, Finished products, Stability samples). Document Preparation & Review (Validation protocols, Report addendum, SOPs, STPs). Method verification and Method Transfers. Instrumentation: LC-MS, HPLC, UPLC, GC, FT-IR, Dissolution, KF, UV-Vis. Data integrity and good documentation practices. Team leadership & Mentorship: Trained and guided junior scientists on analytical techniques. Software: Empower 3, ChemStation, LabSolutions, Open Lab, LIMS, UV probe, Microsoft Office. Proficiency with Microsoft Office for managing data and report. HPLC Troubleshooting and Calibration. Deviation Management & CAPA Implementation
-
Research AnalystCmic, Inc. Jun 2021 - May 2022Hoffman Estates, Illinois, United States• Developed methods for small molecules, oligonucleotides by LC-MS.• Performed sample analysis and validations for PK, TK samples.• Prepared and reviewed validation plans, sample analysis reports, and report addendum for submission to QA.• Prepared study related documents such as protocols, reports and worksheets.• Reviewed data generated by fellow analysts, ensuring accuracy and adherence to method protocols. -
Research And Development ScientistPatrin Pharma, Inc. Apr 2021 - Jun 2021Skokie, Illinois, United States• Preparation of documents for ANDA filing to FDA.• Responding to the queries commented by FDA.• Review, approve technical documents, data report and communicating about progress of project with CDMO, CRO.• Managing projects, collaborating with CRO, manufacturing companies, packaging companies, Testing labs.• Establish GMP compliant laboratory.• Leading all operation and managerial responsibilities for new product development activities: Early product development to scale up and regulatory on analytical aspects of a project through the development pipeline.• Provided analytical testing support for ANDA submission and FDA deficiency responses.• Handling, qualification, and calibration of HPLC instrument.• Involved in the product development and provided inputs as needed.• Attended daily meetings on the ongoing development and reporting. -
Graduate Lab AssistantNortheastern Illinois University Aug 2020 - Dec 2020Illinois, United States• Trained students on the instruments like KF auto titrator, pH Meter, Analytical balance, Precision balance, UV spectrophotometer, HPLC and GC, AAS.• Setting up the analytical instruments for the laboratory.• Troubleshooting the instruments like KF, HPLC, UV, AAS, NMR as required.• Supported faculty with laboratory arrangement.• Preparing required chemical solutions for the labs.• Performed regular lab maintenance duties.• Assisted student’s regarding lab safety. -
Graduate Research AssistantNortheastern Illinois University Jan 2020 - Dec 2020Chicago, Illinois, United States• Developed and validated a HILIC method for analysis of multiple water-soluble vitamins under the guidance of department chair.• Recorded the experimental results and submitted to the guide.• Prepared the samples and buffers required for the study.• For this study, used the various instruments such as HPLC with DAD, HPLC with VWD, pH meter, and analytical balance, Vacuum filtration kit.• Troubleshoots the HPLC while using if required.
-
Research Scientist-IChemo Sep 2018 - Jan 2019Hyderabad, Telangana, India• Led the development and validation of analytical methods for small molecules in solid oral dosage forms, ensuring regulatory compliance and quality standards.• Conducted advanced chemical analysis and stability testing of pharmaceutical samples, ensuring compliance with GMP standards.• Performed method verification and method transfers to QC.• Prepared method development reports, validation reports, SOPs &STPs and reviewed them.• Conducted daily calibrations and preventive maintenance of instruments (HPLC, UV spectrophotometer, dissolution apparatus, Analytical balance, pH meter, KF apparatus) to ensure reliable and accurate results.• Performed the Qualification for Reference/working standards. -
Research AssociateHetero Apr 2015 - Sep 2018Hyderabad Area, India• Performed method development and validation of analytical methods for solid, liquid oral dosage forms.• Performed routine analytical tests (assay, dissolution, RS etc.) for raw materials, in-process, finished products (tablets, capsules, pellets, suspensions, solutions) and stability samples.• Provided technical support to QC in troubleshooting existing analytical methods and ensuring timely and accurate reporting of results.• Led training sessions for junior scientists, enhancing team capabilities in sophisticated instrumentation and data review.• Managed data integrity and regulatory documentation in compliance with FDA and company standards.• Executed the work for analytical related regulatory queries for different markets• Assist in the general operation of the Analytical R&D laboratory, including maintenance of SOP's, training and equipment validation or maintenance.
Madhuri M Education Details
-
Separation Science
-
Gpa 4.0
Frequently Asked Questions about Madhuri M
What is Madhuri M's role at the current company?
Madhuri M's current role is Research Analyst at CMIC, Inc./ Experience in Analytical Research and development/Looking for positions in Analytical development..
What schools did Madhuri M attend?
Madhuri M attended Northeastern Illinois University, Osmania University, Jawaharlal Nehru Technological University.
Not the Madhuri M you were looking for?
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial