
Timeline
Skills
I have expert in oral solid dosage formGenericsFormulation developmentPharmaceuticsDrug deliveryAndaOralSolid oral dosage formsR&dFormulationV&vDissolutionDisintegrationPharmaceutical industryGeneric programmingI have experience in mouth dissolving oral film stripsI have experience in nddsRegulatory affairsSopHplcTechnology transferQuality by designPharmaceutical researchGmpCleaning validationVerification and validationAbbreviated new drug applicationHigh performance liquid chromatographyResearch and developmentStandard operating procedureAbout me
Specialties: M. Pharmacy in Pharmaceutics. I have experience in Formulation Development of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film/ Strips/ Rapid Mouth melting Strips/ Orodispersible strips and Solid Oral Dosage Form. Conducting the formulation research and development of Bench Scale, Lab Scale Phase, Scale-up and Commercialization of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film
Education

Rajiv gandhi university of health science, bangalore
2008 - 2010M. pharmacy pharmaceutics aActivities and Societies: Playing Cricket, Badminton M. Pharmacy (Pharmaceutics)

North maharashtra university
2003 - 2007B. pharmacy pharmacyActivities and Societies: Playing Cricket, internate surfing etc. B. pharmacy
Experience

Flamingo pharmaceutical ltd.
Nov 2007 - Jun 2008Production chemistI have experience in Solid oral dosage form.

Health'n'u therapeutics pvt. ltd.
Oct 2010 - May 2015Executive- fr&d1) I have experience in developing the Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film and the taste masking of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Orodispersible strips2) Literature review and patent searching. 3) Maintaining the project planning system for assigned projects.4) Preformulation and stability studies. 5) Designing and Conducting the experiments6) Formulation Development and process optimization of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film7) Coordination with various departments like Analytical R&D, QC, QA and Production department. 8) Submitting the samples for analysis.9) Involving in Internal audits and effective planning and execution.10) Preparation of MFR, BMR and PDR. 11) Improving, designing and developing new and existing formulations and processes technologies (Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film, solid oral dosage form) and their documentation. 12) Monitoring of new machines, equipments.13) Process standardization for Formulation Development, Bench scale, Lab scale phase, Scale up, Process Validation and Commercialization of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film14) Production problem investigation and trouble – shooting. Show less

Shilpa therapeutics pvt. ltd. (subsidiary of shilpa medicare ltd.)
May 2015 - Oct 20201) Maintaining the project planning system for assigned projects.2) Preformulation and stability studies. 3) Designing and Conducting the experiments4) Formulation Development and process optimization of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film5) Coordination with various departments like Analytical R&D, QC, QA and Production department. 6) Preparation of MFC, BIF and other supporting Documents 7) Preparation of PIF, PDP and PDR Show less
Assistant Manager
Apr 2019 - Oct 2020Sr. Executive-FR&D
May 2015 - Mar 2019

Shilpa medicare ltd
Oct 2020 - nowProcess optimization in Formulation of Solid oral dosage forms.Execution of Trial and Scale-up batches at commercial site.Preparation of documents like PIF, PDP, MFC, BIF, Sampling protocol, Study plan and Batch summary scale up report and PDR.Recommendation for the process parameters in Trial and Scale up batches.Execution of Trial, Scale up, exhibit batches in coordination with AFD, QC, QA and Production department.Coordination with various departments like Analytical R&D, QC, QA, RA and Production department for regular activity Effective daily planning and execution related to work.Research and New Development of Orally Disintegrating strips (ODS).Well acquainted with various ICH, USFDA and CDER guidelines. Preparation and maintenance of SOPs for documentation and equipments.Preparation of form 29 test license files and applied for NOC for test license.Preparation of DCGI files and applied for Form 44.Involved in BE study of solid oral dosage form products. Show less Process optimization in Formulation of Solid oral dosage forms.Execution of Trial and Scale-up batches at commercial site.Preparation of documents like PIF, PDP, MFC, BIF, Sampling protocol, Study plan and Batch summary scale up report and PDR.Recommendation for the process parameters in Trial and Scale up batches.Execution of Trial, Scale up, exhibit batches in coordination with AFD, QC, QA and Production department.Coordination with various departments like Analytical R&D, QC, QA, RA and Production department for regular activity Effective daily planning and execution related to work.Research and New Development of Orally Disintegrating strips (ODS).Well acquainted with various ICH, USFDA and CDER guidelines. Preparation and maintenance of SOPs for documentation and equipments.Preparation of form 29 test license files and applied for NOC for test license.Preparation of DCGI files and applied for Form 44.Involved in BE study of solid oral dosage form products. Show less
Manager FDD
Apr 2021 - nowAssistant Manager FRD
Oct 2020 - May 2021
Licenses & Certifications

Gold medalist
Honors & Awards
- Awarded to Ritesh BirlaGold Medal And Scholarship N.E.T. Pharmacy College, Raichur And Schorlaship Sir Ratan Tata Trust, Mumbai May 2010 Gold Medal Awarded by N.E.T. Pharmacy College, Raichur (2008-2010) And Scholarship Awarded by Sir Ratan Tata Trust, Mumbai(2008-2009).
- Awarded to Ritesh BirlaRatan Tata Scholarship Sir Ratan Tata Scholarship May 1, 2009 I have received Sir Ratan Tata Scholarship in the year of 2009-2010
Languages
- enEnglish
- hiHindi
- maMarathi
- maMarwari
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