Scientific Formulation Expert

2 days ago

Mumbai, Maharashtra, India beBeeFormulation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Research Formulation SpecialistWe are seeking a highly skilled Research Formulation Specialist to join our team. The successful candidate will be responsible for delivering formulations within defined timeframes, developing different formulations, and demonstrating successful stability and scale-up at manufacturing sites.Key Responsibilities:
  • Develop formulations using scientific rationale and excipients to create reproducible prototype formulations.
  • Ensure proper documentation of every trial in log note books and use the information for creation of Product Development Reports.
  • Use QbD wherever required for product and process optimization.
  • Maintain and calibrate equipment, ensuring it is in good working order.
  • Scale up developed formulations to work at engineering batch level.
Deliverables:
  • Conduct literature/patent searches to create drug profiles.
  • Develop prototypes with rationale use of excipients.
  • Perform preformulation studies as required for formulation development.
  • Conduct 6 months accelerated stability studies to ensure stable formulations.
  • Proof of concept studies to demonstrate BE or comparative PK.
  • Scale up studies at 1/10th scale or engineering batch.
  • Technology transfer and manufacturing of Bio/Clinical batches.
Critical Success Factors:
  • Functional/Technical:
    • Schedule and follow all steps to deliver the drug as per QTPP.
    • Select suitable polymers/excipients based on properties or scientific rationale.
    • Evaluate CQA of drug/excipients and estimate its implications for product development.
    • Design processes that are reproducible, scalable, cost-effective, and environmentally friendly.
  • Design of Experiments: Executes experiments as per DOE to optimize product and process.
  • Pharmaceutical Development Report (PDR): Prepares PDR as per Common Technical Document (CTD) module 3 requirements.
  • Project Management: Plans and prioritizes multiple project deadlines to meet product delivery goals.

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