Total 17 years experience in formulation research and development for USA, Europe, Brazil, Canada, China, and ROW countries.
Handled more than 100 molecules successfully and strong technical knowledge on regulated markets.
Following product development report by QBD approach, describe design space, identify CQA's, CPP's ,CMA's and control strategy
Overview
18
18
years of professional experience
3
3
Languages
Work History
Director of Formulation R&D
Bocimed Pharmaceuticals
Shanghai, China
10.2023 - Current
Formulation design, development and smooth execution at plant level batches .
Monitoring stability data of drug products and address agencies queries on time, continues monitoring till to approval stage.
commercial launch batches technical support at plant level batches.
Bioequivalence studies shall be planning against reference Vs Test products, ensure test product bioequivalent to reference product as per regulatory guidelines.
I am responsible for any type of molecules develop very fast track and key role participation to getting approval.
Optimized operational processes using analytics tools to address client-specific metrics.
Evaluated company documentation to verify alignment with regulatory requirements.
Around 8 molecules development going on 2 molecules for execution completed up to Exhibit batches
Senior Scientist II
Hetero labs Limited
Hyderabad, India
09.2016 - 10.2023
Developed NCE-1 molecules , extended release, delayed release and immediate release tablets and capsules.
More than 40 molecules commercialized in Hetero lab limited.
Development on the basis of cost effective formulation for various markets like US, Europe, Brazil, Canada, China and ROW countries.
Liquid, suspensions and powder for Oral suspensions development on priority basis.
Osmotic delivery, bilayer tablets, tri-layer tablets developed as per regulatory requirements.
Senior Research Officer
Glenmark Pharmaceutical Limited
Mumbai, India
02.2010 - 08.2016
Handled all type of molecules for US, Europe, Brazil, China and ROW countries.
More than 20 molecules handled and commercialized.
As per ICH guideline stability data generation and monitoring product life cycle management.
QBD approach based product development.
Team handling and more than 10 molecules handling at a time.
Research Associate
Hetero Labs Limited
Hyderabad, India
06.2007 - 02.2010
Developed various type of molecules like liquids, suspension, Extended Release, Delayed release tablets and Capsules, powder for oral suspension
Sorted data into well-organized formats and transformed into figures
Performed research into study topics to increase knowledge and to provide valuable contributions.
Product development report and master formula card preparation and Batch manufacturing records review.
Pre-formulation, polymorphic evaluation, Stability monitoring of product entire development.
Research trine
DR. Reddy's Laboratories limited
Hyderabad, India
10.2006 - 04.2007
Research development training with Regulated markets like US and Europe
Troubleshot and resolved equipment and process issues
Coordinated and managed laboratory projects and experiments
Batches execution, results compilation and discussion.
Principle Quality Specialist at Endo Pharmaceuticals/ Auxilium PharmaceuticalsPrinciple Quality Specialist at Endo Pharmaceuticals/ Auxilium Pharmaceuticals