Highlights:

Skills:, Developed Solid orals & Parenterals for US market and involved in freeze dried projects and NDA development, • Conducted Pre-formulation studies (drug- excipient compatibility studies, Solubility studies, Filter compatibility stu, • Involved in activities related to execution of Scale up batches and Exhibit batches for in-house products., • Handled equipment like Rapid mix granulator (Lab scale only), Fluid bed processer (for top spray granulation), Tablet, • Interpretation of NMR, IR, DSC & TGA, • Wrote development strategy reports

Senior Research Associate 04/ 2014 - current
TherDose Pharma Pvt Ltd, Hyderabad, Andhra Pradesh India
Industry: Pharmaceutical Formulations
Innovative, result oriented Product Development Scientist with a Ph.D., in Pharmaceutical Sciences with experience in solid oral and sterile dosage form development, technology transfer from R&D to commercial manufacturing and in addition to academic experience. Has good understanding of new drug product development, generic formulation development principles and ICH stability guidelines. Capable of independently designing experiments for optimization of formulations. Looking for a suitable position in the Formulation Development area.
• Formulation Development of Solid Oral and Sterile Dosage Forms for US generic market which included IR, ER tablets, Parenteral dosage forms. • Conducted literature search and reviewed Patents as a part of formulation development. • Conducted Pre-formulation studies (drug- excipient compatibility studies, Solubility studies, Filter compatibility studies, Stopper compatibility studies and container closer compatibility studies). •• Monitored stability studies for prototype formulations and evaluated the stability data to select optimal formulation. • Involved in activities related to execution of Scale up batches and Exhibit batches for in-house products. • Co-ordination with API Research Centre for characterization of API (Particle size determination by Malvern etc.) as a part of formulation development activities. • Co-ordinated with Analytical team for on time analysis of samples • Interpretation of NMR, IR, DSC & TGA • Wrote development strategy reports [includes Product information, Strategies, Key challenges and Project plan]--
Research Associate 12/2011 - 06/2013
Granules India Ltd, Hyderabad, Andhra Pradesh India
Industry: Pharmaceutical Formulations
Innovative, result oriented Product Development Scientist with a Ph.D., in Pharmaceutical Sciences with experience in solid oral dosage form development, technology transfer from R&D to commercial manufacturing and in addition to academic experience. Has good understanding of new drug product development, generic formulation development principles and ICH stability guidelines. Capable of independently designing experiments for optimization of formulations. Looking for a suitable position in the Formulation Development area.
• Formulation Development of Solid Oral and Sterile Dosage Forms for US generic market which included IR, ER tablets. • Developed and transferred an anti-diabetic IR tablet formulation and transferred into commercial manufacturing. • Developed an improved formulation of an anti-diabetic ER tablet formulation and made it ready for tech transfer to commercial manufacturing. • Conducted literature search and reviewed Patents as a part of formulation development. • Conducted Pre-formulation studies (drug- excipient compatibility studies, Solubility studies, Filter compatibility studies, Stopper compatibility studies and container closer compatibility studies). • Designed Prototype formulations, Optimized and finalized Formula composition and Manufacturing process. • Wrote test protocols and procedures for product evaluation • Worked on product transfer from development stage to commercial production for site transfer projects. • Involved in activities related to execution of Scale up batches and Exhibit batches for in-house products. • Handled equipment like Rapid mix granulator (Lab scale only), Fluid bed processer (for top spray granulation), Tablet compression machine, Coating machine (Neo-cota) and instruments like HPLC, UV, pH meter, Osmometer, Head space oxygen analyser, Rotary evaporator • Co-ordination with API Research Centre for characterization of API (Particle size determination by Malvern etc.) as a part of formulation development activities. • Co-ordinated with Analytical team for on time analysis of samples • Interpretation of NMR, IR, DSC & TGA • Wrote development strategy reports [includes Product information, Strategies, Key challenges and Project plan] • Prepared Master Formula Record (MFR), Process Validation Protocol, (Batch Manufacturing Record (BMR), Hold Study Protocol--

Arundhathi Kotte Formulation research and development, in both Solid orals & Parenterals