Rahul Dahale
Assistant Manager In Analytical Research And Development
Kamothe
Summary
Expertise in the analysis & data trending aspects for Oral Solids Dosage forms, Injectable, Oral liquid dosages forms and Suspensions. Excellence in executing feasibility evaluation of analytical methods, method development & validations, writing of validation protocols, reports & other technical quality documents; skilled at conducting validation-related investigations and contributing to improvements in laboratory operations. Involved in various Query response analysis for various regulatory agencies. Supported to solve various plant level issues arrived during analysis of plant analysis for exhibit batches. Hands-on experience on chromatography technologies and data interpretation. Proven success in method development & validation activities in accordance with regulatory guidelines / industry best practice, in a range of analytical techniques. Strong capabilities in providing strategic leadership & technical expertise in analytical method development for release and stability testing of drug substances, Excipients, intermediates & drug product. Skilled in identifying analytical science capabilities & technology tools needed to enable method development, QC testing, and new drug candidate formulation development. Skilled in coordinating with other internal departments to review/approve qualification/validation of analytical methods. Successful in leading analytical method transfer, qualification & validation to commercial QC and as needed at manufacturing locations. Generated Method Development Report, Justifications reports and Test Methods for all the method developments performed. Following ALCOA+ during execution of LNB and maintaining the raw data for method developmental analysis. Leader with effective communication, interpersonal, problem-solving & troubleshooting skills, capabilities in experimental design and execution, capability to work on multiple projects simultaneously, as well as to work independently.
Overview
13
13
years of professional experience
1
1
Language
Work History
Assistant Manager – Analytical Method Development
Par Formulation R&D Pvt Ltd.
10.2019 - Current
- Reviewed analytical documents including data sheets, method development reports and validation protocols.
- Developed and validated analytical methods (UV, HPLC, UPLC) for cleaning, assay, impurities, antioxidant and dissolution across oral solids, injectables and solutions, ensuring ALCOA+ compliance.
- Prepared MDRs, AQbD reports, SOPs and justification documents for organic impurity specifications.
- Executed method equivalency and site transfer activities within defined timelines.
- Addressed plant queries and provided scientific justifications.
- Managed team operations, sample coordination and data interpretation aligned with scientific expectations.
- Mentored and trained team members to foster knowledge sharing and operational excellence.
- Conducted additionally tests including reverse engineering, solubility (BCS/saturated), PSD, KF, auto titration and bulk density.
- Reviewed complex analytical data from techniques like VSM-SQUID, ESR, and Mössbauer spectroscopy for sameness studies.
- Utilized digital documentation platforms such as Veeva, Trackwise, Coupa, and Master Control.
Executive - Analytical Method Development
Mylan Lab
10.2017 - 10.2019
- Executed rapid method development for Dissolution, Assay and RS to support global market extensions.
- Drafted and optimized test methods for analytical procedures.
- Resolved method-related issues from support teams and validation studies.
- Conducted de-formulation studies to quantify excipients.
- Proactively addressed regulatory IRs and CRLs ahead of deadlines.
- Oversaw inventory and logistics to ensure seamless analytical operations.
Junior Manager- Analytical Method Development
Dr. Reddy’s Laboratory
08.2014 - 10.2017
- Designing and executing methods for Dissolution, Assay, RS, and Pharmaceutical Sameness.
- Conducting risk assessments (FMEA) and evaluating formulation data (e.g., dissolution profiles, stability impurities).
- Performing partial and full method validations, including protocol preparation and report review.
- Executing IQ, OQ, PQ for analytical instruments and auditing calibration documentation.
- Creating standard test procedures for assay, related substances, dosage uniformity, blend uniformity, and dissolution in various media.
- Utilizing digital tools like eLN, LIMS, LOTUS, MINITAB, and Design Expert for experimental design and data management.
Assistant Grade I - Analytical Method Development
Sun Pharma Ind Ltd.
11.2013 - 08.2014
- Reviewed, compiled, and monitored analytical results for accuracy and consistency.
- Conducted partial and full validation of analytical methods across multiple dosage forms.
- Performed instrument calibrations (HPLC, analytical balance) and reviewed related documentation.
- Prepared and executed validation protocols for tablets, capsules, injections, and aerosols.
- Ensured timely cGMP compliance and maintained traceable documentation throughout validation activities.
- Reported method limitations, conducted hypothesis studies, and performed root cause analysis aligned with regulatory guidelines.
Trainee - Analytical Method Development
Famy Care Ltd.
06.2012 - 11.2013
- Reviewed and compiled analytical results including dissolution profiles and degradation impurities in stability samples.
- Developed complex analytical methods for low-strength drug formulations.
- Conducted partial and full validation of methods for assay, related substances, and dissolution.
- Prepared validation protocols and reviewed partial validation reports.
- Calibrated instruments (HPLC, dissolution apparatus, analytical balance) and verified calibration documentation.
- Analysed innovator products, F&D samples, and stability batches; processed and reported data.
- Drafted standard test procedures for assay, related substances, dosage uniformity, blend uniformity, and dissolution in various media.
Education
M. Pharm - Pharmaceutical Analysis
UDPS, Nagpur
05.2012
B. Pharm - undefined
BKCP, Sakoli
01.2010
Skills
DECLARATION
Hereby declare that the above information is true & correct to the best my knowledge & belief. Place: Navi Mumbai. Date: Yours faithfully, Rahul Ravindrakumar Dahale
INSTRUMENTS MANAGED
- HPLC & UPLC of Agilent, Waters, Shimadzu with Empower, Chromeleon and LC solution.
- Waters HPLC with RI Detectors.
- Particle size analyzer (Mastersizer 3000).
- UV-visible spectrophotometer of Shimadzu.
- Infra-red spectrophotometer (Agilent).
- Karl Fischer Titrator(Metrohm)
- Dissolution apparatus of Electro lab, Distek and Lab India
Accomplishments
Got the above and beyond award for work in Sitagliptin and metformin HCl tablets project
Got the the spot award for Q1/Q2 study for FDA submission.
Timeline
Assistant Manager – Analytical Method Development
Par Formulation R&D Pvt Ltd.
10.2019 - Current
Executive - Analytical Method Development
Mylan Lab
10.2017 - 10.2019
Junior Manager- Analytical Method Development
Dr. Reddy’s Laboratory
08.2014 - 10.2017
Assistant Grade I - Analytical Method Development
Sun Pharma Ind Ltd.
11.2013 - 08.2014
Trainee - Analytical Method Development
Famy Care Ltd.
06.2012 - 11.2013
B. Pharm - undefined
BKCP, Sakoli
M. Pharm - Pharmaceutical Analysis
UDPS, Nagpur