Nisarg Modi, Ph.D. Email & Phone Number

New York, Ny, Us

Long Island City, Ny, Us

• Lead a team of 4 associates to progress 4 small molecules from ideation phase to phase-I proof of concept studies.• Collaborated with cross-functional teams in regulatory affairs, pre-clinical and clinical development, and business development for project evaluation and partnership.• Drive the strategic direction of the project and accountable for the implementation and execution of initiatives and strategize creative solutions for complex formulation development for external customers.• Act as a Subject matter expert (SME) for clients, contract research organization (CRO) and contract manufacturing organization (CMO).• Lead the development of TRPL Technology and Innovation strategy plan for R&D portfolio and provide recommendations to the executive leadership team.• Provide scientific assessment to the executive leadership team for project viability and prioritization.

Long Island City, Ny, Us

• Authored request for proposal (RFP), product development report (PDR), technology transfer reports (TTR) for external contract research organization (CRO) and Contract manufacturing organization (CMO)• Collaborated with external pre-clinical CRO to initiate and mange pre-clinical studies including selection of pre-clinical CRO, identify disease specific pre-clinical model, develop and review protocols and reports, evaluate the PK data, and monitor the execution process at partner CRO.• Managed TRPL’s patent portfolio by driving the innovative strategy for product development, drafting response to USPTO office action and construct claims for longer lifespan of the patent. • Performed pre-formulation (solubility and compatibility enhancement), formulation (permeability and stability improvement), process and analytical development studies

Long Island City, Ny, Us

• Developed Technology Transfer documents for CMO site.• Development and Validation of stability indicating HPLC methods for drug molecules by applying analytical Quality based Design (QbD) approach• Carrying out In-Vitro study for semi-solid Dosage forms by using different mathematical models and predicted steady state concentration in-vivo for different formulations• Performing various pre-formulation studies such as solubility study, pH dependent solubility study, Rheological studies.• Optimizing formulation by applying Design of Experiment (DOE) and QbD approach.• Conducting different in process and finish product tests for semi-solid dosage forms such as stability, viscosity, elasticity of formulation and In-vitro study.

Brookville, New York, Us

• Conducting literature reviews on latest research articles related to Material science and Transdermal drug delivery system.• Formulating Transdermal Drug Product using various permeability enhancers and carried out In-vitro studies using human cadaver skin and cellulose membrane.• Performing crystal characterization using DSC and PXRD. • Evaluating rheological properties of different polymers using Rheometer.• Validate and Use of UV and HPLC to determine the unknown concentration.

Brookville, New York, Us

Advise students to register their course works.Help faculty members in admission processPrepared proposed class schedule every semester

• Developed different formulation for solid dosage forms• Performed dissolution, assay and purity testing using HPLC.• Executed IPQC tests for finished products such as disintegration, weight variation, hardness, friability and etc.• Documented the reports after completion of every project on the basis of the research articles and obtained data.

Ahmedabad, Gujarat, In

Conducted IPQC tests as per the country's requirements such as hardness, friability, weight variation, disintegration, LOD, and dissolution.Carried out the stability study of finished product using specific requirements.Prepared and reviewed the production documents such as Batch Manufacturing Record, Master Formula Card, Process Validation Protocol, and Validation Summary Report as per US FDA requirements.Fixed the critical parameters for the large scale production using validation batches.Performed formulation and pre-formulation study for drug products.

Formulation Department)Recorded the in-process production parameters in Batch Manufacturing Record.Conducted the prospective process validation as per FDA regulation and guidelines.Gained intensive hands-on experience in utilizing RMG, compression machine, hardness and thickness tester by Erweka Ltd., and also on Electro Lab's friability tester and Disintegration apparatus.

Phd, Pharmaceutical Science

Master, Pharmaceutical Science

B.Pharm, Pharmaceutical Science