Since December 2013
•To conduct literature review, prior art experiment design of product and Proof of Concept (POC) of experimental work prior to formulation studies for customer Formulation and development of solid oral dosage form for Japan market and US market. •Responsible for Initiation, planning and execution of stable, scalable and bioequivalent formulation for Japan Market and US market. •Conduct risk analysis, identify resource requirement and define project deliverable with PMO and clients. •Involved in patent circumvention, search of prior art, state of art and use of it in experimentation work.
April 2013 --- December 2013
Formulation and development of solid oral dosage & Liquid dosage form for Europe market •To prepare the Proof of Concept (POC) of experimental work prior to formulation studies for customer. •To Conduct Literature review, prior art experiment design of the product identified for development. •Involved in patent circumvention, search of prior art, state of art and use of it in experimentation work. •Interaction with Cross functional Team members of various teams like Analytical, IPR, RA, Packaging development for product updates. •Identification of Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Attributes (CPAs) and subsequent use of Design of experimentation (DOE).
Formulation development NDDS
March 2011 --- April 2013
Development of Solid oral dosage form for regulated & semi regulated markets. •Responsible for Development of stable, scalable and bio equivalent formulation for US and Europe Market. •Managing all activities from project kicks off to completion by coordinating with all cross functioning teams work plan and Delivery schedules. •To study the individual patent with respect to the invalidation or infringements of the enforced granted or published patents. •Performing prototype development, stability, pilot, and optimization trials at bench level. •Master document preparation like MFR, Stability protocol, Validation protocol, Pilot batch BMR etc.
June 2011 --- December 2011
I did my M. Tech (Pharma) disseratation work in MARC, Bangalore in formulation development department.
Analytical thinkingCollaborationApproachabilitySelf-confidenceCuriosityStrategic thinking
R&D Biochemistry Lab scale batchesBioavailabilityDrug development processDrug regulatory authoritiesEarly development stageGood Manufacturing Practice (GMP)Gynecologic oncologyIn VitroIn VivoNew Drug Application (NDA)Pharmaceutical IndustryPharmacodynamicsPharmacokineticspharmacologyPharmacyPhases of clinical development (phase I to IV)Problem-solving methods and troubleshootingProcess improvementProduct designProject ManagementUnderstanding of regulatory guidelines
Skills and Expertise
Lab scale batchesDevelopment of late-stage cGMP production processes
Master of Technology (M.Tech.) in Pharmaceutical Technology from North Maharashtra University in 2011
Bachelor of Pharmacy (B.Pharm.) in from SSJIPER, Jamner in 2009