Formulation and Development of oral solids and liquid products for regulated markets.

Formulation and Development of Solid Dosage Forms (IR, ER and MUPS) for US, Japan, EU and Row Market. Well attuned to the QBD Approach (DOE, Minitab software and Six sigma principles)

Formulation and Development of IR and MR products for US, EU and Japan market. Well attuned to the QBD Approach (DOE and Minitab software)

Timely development of drug products those are non-infringing, robust, stable and bio-equivalent to the reference product for US and European market (Immediate Release and Modified Release Oral dosage form).

JOB DESCRIPTION:• Timely development of drug products those are non-infringing, robust, stable and bio-equivalent to the reference product for US and European market.• Developing Solid Oral dosage forms using Qbd Components. Responsible for reports and documentation (BMR/MFC, Review of BIO protocols, Validation protocols, CTD / ANDA documentation, Product development reports, implementation of Quality based Design –QbD ( Design Expert and Minitab Software), Question based review -QbR, Quality overall summary- QOS etc. in line with regulatory requirement. • To plan, execute and monitor Literature survey, Patent status, API and Innovator Characterization and Preformulation study, scale up and Exhibit batches for US and Europe market.• Designs and undertakes quality scientific experimentation to develop robust solid oral dosage formulations and processes. Evaluation of Analytical results and trouble shooting• Enhancing preparation of various documents like MFC (Master Formula Card), Batch Manufacturing Record (BMR), Pre Validation Protocol, Product Development Report, Specifications, SOP's, Justification reports etc.• Acquainted with all major formulation techniques like Direct Compression, Roller Compaction, Wet Granulation and Fluid Bed Processing• Resource organization and co-ordination with relevant departments like Purchase and Procurement, Production plant, ADL, Specification cell, Documentation cell, New Product Development team, Packaging Development ,QC, QA, etc.• Familiar with operation of all major equipments like Rapid Mixer Granulator, Roll Compactor, FBP, various types of Mill (Quadro Co mill, Multimill), Blenders, Compression (Single & Bilayer) and Coating machines. • Also familiar with operation of analytical equipments like Dissolution tester, UV spectrophotometer

Work on project entitled " Formulation development and optimization of IR tablet by using design of experiment approach."