Formulation & Development (F&D) Executive / Officer

Job Title: Formulation & Development (F&D) Executive / Officer

Experience: 1–5 years (Pharmaceutical Formulation)
Qualification: B.Pharm / M.Pharm (Pharmaceutics / Pharmaceutical Technology)

Job Purpose

To assist in the design, development, and documentation of new and existing formulations, and to prepare technical documentation required for regulatory submissions and product transfers.

Key Responsibilities

• Prepare and maintain Formulation Development Reports (FDRs) and Product Development Reports (PDRs)
• Compile data for CTD Module 3 (Quality) in coordination with Regulatory Affairs
• Support preparation of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR)
• Document and interpret stability studies, analytical method validation, and process validation data
• Support technology transfer to production units by providing technical documentation
• Coordinate with RA, QA, QC, and Production teams for data collection and documentation
• Prepare QbD/DoE reports, comparative dissolution profiles, and bioequivalence data summaries
• Maintain archives of development documents as per GDP and regulatory guidelines
• Assist in generating product justification and stability summary reports for submissions

Required Skills

• Knowledge of formulation development (solid oral / liquid / semi-solid dosage forms)
• Familiarity with ICH guidelines and CTD structure
• Proficiency in MS Office and technical report writing
• Understanding of stability study design and analytical interpretation
• Strong collaboration skills with RA and QA departments

Key Competencies

• Strong analytical and scientific thinking
• Excellent technical writing and documentation abilities
• Attention to detail with a compliance-focused mindset
• Team-oriented, proactive, and deadline-driven

Job Type: Full-time

Pay: ₹18,359.71 - ₹40,215.47 per month

Benefits:

• Paid sick time
• Provident Fund

Work Location: In person