Expert Details
Formulation Science, Formulation Chemistry
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 dry powders by lyophilization technique and evaluated for their vitro/in vivo aerosolization properties.
Interpersonal Skills:
+ 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.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| 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 |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2015 to 2021 | Employer: Hetero | Title: Group Leader | Department: R & D |
Responsibilities: Involved in the development of liquid injection, lyophilized products, suspension product, ophthalmic gel, ready-to-use formulations, and Drug-device combination products for the Regulatory market (ANDA & 505b2) and domestic market. Led a team of 3 to 4 formulation scientists. Filed 4 PCT applications and 4 Indian patent applications. Working closely with cross-functional teams including the Analytical team, QA, IPR, Purchase, Plant, Project management, and Regulatory team for smooth execution of projects. Manufacturing pre-formulation and prototype development batches using the Quality-by-Design concept (QBD) and addressing FDA deficiencies. Preparation of prototype batches for stability study, evaluation of analytical data, documentation and result interpretation, finalization of finished product specification, and manufacturing process optimization. Preparation and review of general and technical documentation like Product Development Report, and other Scientific Reports like Material Compatibility Study Report, Filter Compatibility Report, Filter validation report, Reconstitution Study Report, Stability Protocols, and Reports, product specification, MFC, BOM etc. Conducted Scale-up and Exhibit batches manufacturing, technology transfer activity, and preparation of supporting documents like product development reports for the product filing. Patent analysis, preparation, and review of non-infringing development strategies, NDA & 505b2 strategies. Involved in general lab management, planning, and budget activities. Manage timelines and risk assessment of projects, timely execution, and delivery of products. Supporting team members for day-to-day activities, and knowledge sharing for smooth execution of product development. Identifying CMO, conducting the audit for plant facility as per GMP requirement, and submitting the audit report to management. |
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| Years | Employer | Title | Department |
| Years: 2014 to 2015 | Employer: Sun Pharmaceutical Industries Ltd | Title: Research Officer | Department: R & D |
Responsibilities: Handled formulation development activities of SVP, ready-to-use use injectable products, 50 mL PFS product. Planning and performing research experiments including Reference Drug (RLD) characterization, pre-formulation studies, stability and studies, and formulation design using QbD principles. Preparation of testing protocols for trial and submission batches. Preparation and review of non-infringing development strategies, NDA & 505b2 strategies Preparation of test license (Form 29), Import license (form 11), selection of RLD product development report. Pre-formulation studies, Stability studies. Literature search (Orange Book, USPTO, Science Directory, EMA, Daily med, Espacenet, free Patents Online, Pharmacopoeias, Merck Index, Martindale), Innovator product evaluation. Supported Scale-up and Exhibit batches activities. |
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| Years | Employer | Title | Department |
| Years: 2013 to 2014 | Employer: Emcure Pharmaceutical Ltd | Title: Senior Research Fellow | Department: R & D |
Responsibilities: Planning and performing research experiments to develop solid oral dosage forms and Liquid injections for the regulatory market. Pre-formulation studies, RLD Characterization, Stability studies. Literature search (Orange Book, USPTO, Science Directory, EMA, Daily med, Espacenet, free Patents Online, Pharmacopoeias, Merck Index, Martindale), Innovator product evaluation. Preparation & review of development strategies, regulatory documents, and patent analysis. Supported execution of scale-up and Exhibit batches. Preparation of the monthly product review report, Product Development Reports (PDR), BOM, and MFC, stability study protocols, test license (Form 29), and Import license (form 11). |
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| Years | Employer | Title | Department |
| Years: 2010 to 2010 | Employer: GSK Consumer Healthcare Ltd | Title: Trainee Formulation Scientist | Department: R & D |
Responsibilities: Formulation development and process optimization for Oral liquids, oral suspension, and topical analgesic gel. Pre-formulation and formulation development activities, manufacturing process optimization, stability study, in-vitro release, skin permeation study using synthetic membrane & Porcine skin with the help of Franz Diffusion Cell, in-vitro release studies, and stability studies. Literature search (USPTO, Science Directory, EMA, Daily med, Espacenet, free Patents Online, Pharmacopoeias, Merck Index, Martindale, research articles), Innovator product evaluation. |
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| Years | Employer | Title | Department |
| Years: 2021 to Present | Employer: Undisclosed | Title: Senior Scientist | Department: R & D |
Responsibilities: Involved in the development of Lyophilized biological drug products for the Regulatory market. (NDA products) Led a team of 2 formulation scientists. Work closely with global and regional cross-functional teams to develop and execute projects as per priority to meet management goals. Monitored product development activities and communicate progress and highlight potential risks and complexities related to projects. Development and optimization of the lyophilized cycle for the NCE products, thermal characterization, troubleshooting of lyophilized product defects, lyophilized cycle robustness study, stability study evaluation. Preparation of prototype batches for stability study, evaluation of analytical data, documentation and result interpretation, finalization of finished product specification, manufacturing process optimization, and data presentation to the global team. Preparation and review of general and technical documentation like Product Development Report, Lyophilization cycle development report, lyophilization cycle robustness study report, Monthly activity report, Stability Protocols & Reports, product specifications etc. Part of the BLA preparedness team for regulatory submission of product. Involved in the laboratory facilities management as per EHS & QA requirements, maintenance & calibration of R&D instruments/equipment, new Equipment / Instrument qualification as per URS, and review of qualification documents. Material management, supervision, knowledge sharing, and supporting team members on day-to-day activities. |
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International Experience
| 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. |
Career Accomplishments
| Associations / Societies |
|---|
| Member: NSS (National Social Service) BITS Pilani Give India (supporting meal of orphan child) |
| Licenses / Certifications |
|---|
| 1. Six Sigma Yellow Belt; 6SigmaStudy; Certificate 2. Introduction to Project Management; SkillUp by Simplilearn; Certificate |
| Professional Appointments |
|---|
| 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 IT Nano Conference at Northeastern University in Boston, USA Awarded Travel grant by Northeastern University, Boston to attend 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. 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 |
|---|
| Patents: 9 Publications: 10 Poster Presentations: 4 |
Language Skills
| Language | Proficiency |
|---|---|
| English | Proficient |
| Hindi | Proficient |
| Marathi | Proficient |
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