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Opening for Research Scientist Formulation.

Keywords / Skills : Project Management, Pharmaceutical Development Report (PDR), Design of Experiments, Formulation and Product Development

7 - 14 years
Posted: 2019-06-04

Nationality
India
Industry
Pharmaceutical
Function
Pharmaceutical/Biotechnology
Role
Research Scientist
Education
Master of Pharmacy (MPharm)
PhD
Posted On
4th Jun 2019
Job Ref code
GH/PHL/JC//04062019/
/84298/Research Scie
ntist Form
Job Description
  • Development of formulation using scientific rationale in use of excipients to create a reproducible prototype formulation.
  • Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing.
  • Use of QbD wherever required for Product and process optimization.
  • Ensure proper upkeep, maintenance and calibration of the equipment.
  • Ensure scale up of the developed formulation works at engineering batch level.
  • Development of the patent non-infringing strategy for product development.
  • Preparation of regulatory documents for PK study and marketing approval from DCG (I).
  • Preparation of Pharmaceutical Development report for Quality module of CTD.
  • Literature/Patent search to create drug profile
  • Prototype development with rationale use of excipients
  • Pre-formulation study as may be required for formulation development
  • Conduct 6 months accelerated stability studies to ensure stable formulation
  • Proof of concept studies to demonstrate BE or comparative PK as the case may be
  • Scale up studies at 1/10th scale or engineering batch
  • Technology transfer and manufacturing of Bio/Clinical batch


About Company

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