Biography
Mansi Shah, M.S, Ph.D., is currently a Research Scientist at Amneal Pharmaceuticals, NJ, USA. Prior to joining Amneal, Dr.Shah has also worked as a Formulation Scientist at Hi-tech Pharmacal-An Akorn Company, USA. At a very young age, she received her Ph.D. in Industrial Pharmacy, Pharmaceutical Sciences from St.John’s University, NY, USA in 2013. ”. Dr. Shah has done extensive research to develop an oral drug delivery system for drug molecules which suffers low bioavailability due to poor aqueous solubility and high first pass metabolism. She has completed her M.S. in the same major from the same university in 2009. She has also served as a Scientist in few other pharmaceutical companies. Dr. Shah has been recipient of several awards at International and local conferences including travel-ship award in AAPS-2012 from Merck. She is also a recipient of Graduate scholarship award by NJPhAST. She has presented her research at both national and international conferences. Dr. Shah is a very young, enthusiastic, and focused with a keen scientific knowledge.
https://www.linkedin.com/in/mansi-shah-9b240017
https://www.researchgate.net/profile/Mansi_Shah18/info
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https://www.linkedin.com/in/mansi-shah-9b240017
https://www.researchgate.net/profile/Mansi_Shah18/info
Summary
Pharmaceutical industry and industry-related experience in the design and development of a variety of dosage forms.
Experienced in pre-formulation, lab-scale formulation development, scale up, process optimization, and tech-transfer-troubleshooting product development using Qbd and cGMP principles.
Successful in designing and execution of non-patent infringing product development strategies resulting in ANDA filings
Specialties: Formulation Development and characterization
Immediate, Controlled Release and Extended Release Matrix Tablets
Oral Suspensions, solutions, Topical formulations, Emulsion, microemulsion and Nanoparticulate drug delivery systems, Nasal solutions and suspensions development and characterization for Nasal bioequivalence
Experienced in pre-formulation, lab-scale formulation development, scale up, process optimization, and tech-transfer-troubleshooting product development using Qbd and cGMP principles.
Successful in designing and execution of non-patent infringing product development strategies resulting in ANDA filings
Specialties: Formulation Development and characterization
Immediate, Controlled Release and Extended Release Matrix Tablets
Oral Suspensions, solutions, Topical formulations, Emulsion, microemulsion and Nanoparticulate drug delivery systems, Nasal solutions and suspensions development and characterization for Nasal bioequivalence
Experience
Postdoctoral Fellow
UTMB
Research Scientist
Amneal Pharmaceuticals
Formulation Scientist
Hi Tech Pharmacal
•
Designing, conducting and supervising formulation development, process
optimization, scale up and manufacturing process for ANDA submissions
for nasal, oral, topical liquids and semi-solid dosage forms utilizing
the QbD, CMC and cGMP regulations
• Collaborated and communicating with multidisciplinary teams to troubleshoot product development issues
• Evaluation of stability of selected formulations at various storage conditions to assure minimum of two year shelf-life for new dosage forms
• Develop specifications for in-process, finished product, stability and packaging components
• Write and review master formulas, batch records, test procedures, stability protocols and reports, and product development reports
• Design and execute in-vitro testing protocols for nasal solution and suspension, oral, topical liquids and semi-solid dosage products as per FDA requirements
• Design and execute experiments to respond to FDA comments on pending new products
• Source and evaluate API, excipients, packaging components to assure that Hi-Tech product is comparable to RLD
• Document all product development activities as per the SOPs and cGMPs
• Collaborated and communicating with multidisciplinary teams to troubleshoot product development issues
• Evaluation of stability of selected formulations at various storage conditions to assure minimum of two year shelf-life for new dosage forms
• Develop specifications for in-process, finished product, stability and packaging components
• Write and review master formulas, batch records, test procedures, stability protocols and reports, and product development reports
• Design and execute in-vitro testing protocols for nasal solution and suspension, oral, topical liquids and semi-solid dosage products as per FDA requirements
• Design and execute experiments to respond to FDA comments on pending new products
• Source and evaluate API, excipients, packaging components to assure that Hi-Tech product is comparable to RLD
• Document all product development activities as per the SOPs and cGMPs
Ph.D.
St. Johns University
Ph.D.
project “Preparation, in vitro evaluation, statistical optimization and
in vitro absorption mechanism of carvedilol-loaded solid lipid
nanoparticles for oral delivery”
• Preformulation studies : Performed screening of components, drug-excipients interaction, solubility and partitioning studies
• Formulation development : Studied the effect of formulation variables i.e. lipid and surfactant concentration on particle size using design of experiments before loading the drug, blank nanoparticles were prepared using fractional factorial design and therafter, optimized formulation were obtained using full factorial design.
• Characterization: Particle size, entrapment efficiency, drug release, X-ray diffraction
• Elucidation of intestinal lymphatic absorption mechanism from solid lipid nanoparticles using Caco-2 cell line as in vitro model
• Assisted fellow graduate students with the projects such as solid dispersions, liposomes, microemulsion, controlled release tablets
Was actively involved in projects related to special and modified release formulations: microemulsion, solid dispersion, liposomes, polymeric nanoparticles, matrix tablets.
In addition, I have a teaching experience of more than 2 years in the area of pharmaceutics-laboratory to the undergraduate students at St.John’s University.
• Preformulation studies : Performed screening of components, drug-excipients interaction, solubility and partitioning studies
• Formulation development : Studied the effect of formulation variables i.e. lipid and surfactant concentration on particle size using design of experiments before loading the drug, blank nanoparticles were prepared using fractional factorial design and therafter, optimized formulation were obtained using full factorial design.
• Characterization: Particle size, entrapment efficiency, drug release, X-ray diffraction
• Elucidation of intestinal lymphatic absorption mechanism from solid lipid nanoparticles using Caco-2 cell line as in vitro model
• Assisted fellow graduate students with the projects such as solid dispersions, liposomes, microemulsion, controlled release tablets
Was actively involved in projects related to special and modified release formulations: microemulsion, solid dispersion, liposomes, polymeric nanoparticles, matrix tablets.
In addition, I have a teaching experience of more than 2 years in the area of pharmaceutics-laboratory to the undergraduate students at St.John’s University.
Preparation,
in vitro evaluation and statistical optimization of carvedilol-loaded
solid lipid nanoparticles for lymphatic absorption via oral
administration.
Preparation,
in vitro evaluation and statistical optimization of carvedilol-loaded
solid lipid nanoparticles for lymphatic absorption via oral
administration.
Formulation scientist
Apex Pharmaceuticals
Formulation Scientist at Apex Pharmaceuticals, NJ.
• Responsible for pre-formulation and formulation development of different oral solid dosage forms for modified release, direct compression and dry and wet granulation techniques
• Involved in scale up from lab scale to mid size scale batches
• Performed stability studies and analysis on the optimized formulation batches
• Responsible for pre-formulation and formulation development of different oral solid dosage forms for modified release, direct compression and dry and wet granulation techniques
• Involved in scale up from lab scale to mid size scale batches
• Performed stability studies and analysis on the optimized formulation batches
Intern
Zydus Cadila.
•
Involved in various manufacturing and packaging process for tablets,
injections, soft gelatin and hard gelatin capsules, water systems,
hormone & aerosol formulations
• Responsible for storage and maintenance of materials in Ware house and Central Pharmacy
• Involved in data process and keeping data in Master Formula Batch Record
• Responsible for storage and maintenance of materials in Ware house and Central Pharmacy
• Involved in data process and keeping data in Master Formula Batch Record
Honors & Awards
AAPS-2012, Travelship Award
Merck
Merck Sponsored graduate student Travelship.
2013 NJPhAST GRADUATE SCHOLARSHIP
NJPhAST
Publications
Preparation, in vitro evaluation and statistical optimization of carvedilol-loaded solid lipid nanoparticles for lymphatic absorption via oral administration.(Link)
Pharmaceutical Development and Technology
March 2013Elucidation of intestinal absorption mechanism of carvedilol-loaded solid lipid nanoparticles using Caco-2 cell line as an in-vitro model(Link)
Pharmaceutical Development and Technology
Education
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Awesome
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