Junior Executive, R&D-Formulation & Development

Job Summary

Key Responsibilities

• Literature Survey & Research:
• Conduct detailed literature reviews to support new product development initiatives.
• Evaluate reference products, patents, regulatory status, and formulation strategies.
• Pre-Formulation Studies:
• Perform physicochemical characterization of API and excipients.
• Assess compatibility, solubility, and stability as part of pre-formulation studies.
• Formulation Development:
• Design and develop robust formulations for tablets and pellets.
• Optimize process parameters through laboratory and pilot-scale trials.
• Stability Studies:
• Conduct stability studies as per ICH guidelines and internal SOPs.
• Interpret results and recommend necessary formulation or process adjustments.
• Process Validation:
• Coordinate and execute process validation batches in the production department.
• Ensure compliance with GMP and validation protocols.
• Technology Transfer:
• Prepare and review complete technology transfer documentation (TTD).
• Facilitate successful scale-up and handover of developed products to manufacturing.
• Troubleshooting:
• Provide technical support for commercialized products to resolve formulation or process issues.
• Documentation & Record-Keeping:
• Prepare and update Product Development Files (PDF), Product Logbooks, and Instrument Logbooks regularly.
• Draft and review documents such as QAQN (Quality Assessment & Qualification Note), MFR (Master Formula Record), and FPS (Finished Product Specification).
  

Qualifications

• Education: B.Pharm / M.Pharm in Pharmaceutics or Pharmaceutical Technology.
• Experience: 1–3 years of relevant experience in F&D/R&D, preferably in OSD (tablets/pellets) formulation development in a regulated environment.