Expert in Formulation Science, Formulation Chemistry
Expert ID: 736429 India
+ M. Pharm; Ph.D. with 8+ years industrial experience in Pharmaceutical Industry.
+ Working on ANDA and 505 (b)2 projects.
+ Ideation - generation of new ideas and processes that strengthen the company’s product pipeline. Preparation and review of non-infringing development strategies, NDA & 505b2 strategies, patent analysis, patent publication.
+ Project Management, planning of various activities, and coordination with Cross-Functional Teams for procurement of API, Excipients, Equipment/Instruments for the developmental activities.
+ Planning, Support, and Execution of lab-scale development batches, process optimization. Periodic review of the developmental work and guiding the team members in planning and execution of the project as per stipulated timelines
+ Interpret results, evaluate data, draw relevant conclusions; supervise project-related activities. Review and approve of various documents like Product Development Report, and other Scientific Reports like Material Compatibility Study & Report, Stability Protocols, and Reports, product specification, MFC, BOM, etc.
+ Provide scientific and technical guidance; perform information and literature searches; actively drive knowledge exchange, present scientific/ technical results internally and contribute to publications, presentations, and patents.
+ Identifying CMO, conducting an audit for plant facility as per GMP requirement, and submission of audit report
+ Execution of Scale-up & Exhibit batches and Technology Transfer of developed products for smooth launching of new products
+ Experience in technology transfer activities, troubleshooting, market Complaints.
+ Involved in new Injectable R & D set-up.
+ To review SOPs related to laboratory equipment/instruments.
+ To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents.
Research Experience: Ph. D.
‘Stealth Polymeric Nanocarrier for Sustained Pulmonary Delivery of Drugs and Gene in Cystic Fibrosis’
Cystic fibrosis is a genetic disorder caused due to the mutation in the CFTR gene following lung infection and inflammation. This work includes the development of platform technology of nanoparticulate formulation comprised of antibacterial agent and CFTR gene for effective treatment of Cystic fibrosis. Optimized nanoparticulate formulations were evaluated for their ability to interact with mucus and lung epithelial cells. Then, the antimicrobial activity of the developed formulations against P. aeruginosa was investigated. Also, the ability of the developed nanoparticulate formulation to deliver CFTR gene and correct CFTR function is evaluated in CFBE cell line. Finally, nanoparticles were engineered into Expert powders by lyophilization technique and evaluated for their vitro/in vivo aerosolization properties.
+ Team player, quick learner, a good listener and punctual, hard worker, self-motivated, resourceful, innovative with ability to share and exchange ideas, critical analysis of research articles and patents.
+ Flexible and adaptable to change.
Expert may consult nationally and internationally, and is also local to the following cities: Hyderabad
|Year: 2013||Degree: Ph. D.||Subject: Pharmaceutics||Institution: The M.S. University of Baroda|
|Year: 2010||Degree: M. Pharm||Subject: Pharmaceutics||Institution: BITS Pilani|
|Year: 2008||Degree: B Pharm||Subject: Pharmaceutics||Institution: Pune University|
|Years: 2015 to Present||Employer: Undisclosed||Title: Group Leader||Department: R & D||Responsibilities:
|Years: 2014 to 2015||Employer: Sun Pharmaceutical Industries Ltd||Title: Research Officer||Department:||Responsibilities:|
|Years: 2013 to 2014||Employer: Emcure Pharmaceutical Ltd||Title: Senior Research Fellow||Department:||Responsibilities:|
|Years: 2010 to 2010||Employer: GSK Consumer Healthcare Ltd||Title: Trainee Formulation Scientist||Department:||Responsibilities:|
|Years||Country / Region||Summary|
|Years: 2012 to 2013||Country / Region: Canada||Summary: McGill University, Montreal, Canada: Evaluation of the efficacy of nanoparticles in cell culture for effective delivery of CFTR gene and correction of CFTR defect. Also performed transformation, DNA isolation and purification, RE digestion, Gel electrophoresis, SDS PAGE and Western blot. Evaluation of effectiveness of antibiotic loaded NPs as compare to free drug for eradication of P. aerugenosa strain isolated from CF patients.|
|Associations / Societies|
NSS (National Social Service)
Give India (supporting meal of orphan child)
|Organizing committee member at ‘WORKSHOP ON NANOCONSTRUCTS’ organized by Pharmacy Department, The M. S. University of Baroda, Vadodara
Trainer at the workshop on nanoconstructs, at The M. S. University of Baroda, Vadodara
|Awards / Recognition|
|Selected for Novartis Biotechnology Leadership Camp
Awarded Travel grant by Department of Science and Technology, New Delhi to attend 1st IT Nano Conference at Northeastern University in Boston, USA
Awarded Travel grant by Northeastern University, Boston to attend 1st IT Nano Conference at Northeastern University in Boston, USA
Selected as Graduate Research Trainee by the Canadian Bureau of International Education (CBIE) to pursue research in the Department of Physiology, McGill University under the auspices of the Canadian Commonwealth Scholarship Program (CCSP) from the Department of Foreign Affairs and International Trade Canada.
Oct 2012: Awarded Department of Foreign Affairs and International Trade (DFAIT) Commonwealth Graduate Award by the Canadian Bureau of International Education (CBIE)
Awarded Sr. research fellowship from Indian Council of Medical Research
Awarded Jr. research fellowship under the project DBT-MSUB-ILSPARE
Awarded UGC GATE Fellowship during Master of Pharmacy by Government of India.
|Publications and Patents Summary|
Poster Presentations: 4
Fields of Expertise
cosmetic product formulation, baby personal care product, personal care product, biopharmaceutical product development, injectable pharmaceutical product, ophthalmic pharmaceutical product, oral drug delivery, sanitizer, parenteral drug delivery, parenteral product, cosmetic product development, nanoparticle, tablet, topical drug therapy, over-the-counter topical drug product development