Department: Research & Development (R&D;)
Location: Sachana Plant
Designation: Manager / Sr. Manager / AGM – Formulation & Development (F&D;)
Reports To: Head – R&D;
Formulation Development - JD
• Develop and optimize formulations for sterile injectable products.
• Design and execute laboratory trials for current product development.
• Conduct pre-formulation and compatibility studies.
• Evaluate excipients, APIs, and packaging materials.
• Develop liquid, lyophilized, and ophthalmic formulations.
• Develop manufacturing processes for sterile products.
• Perform scale-up and exhibit batch activities.
• Troubleshoot formulation and manufacturing issues.
• Support process validation and cleaning validation activities.
• Ensure successful technology transfer from R&D; to manufacturing.
• Prepare development reports and technical documents.
• Review CTD/ACTD sections related to formulation development.
• Support dossier preparation for domestic and export markets.
• Ensure compliance with cGMP, WHO, EU, USFDA, and MHRA requirements.




• Participate in regulatory audits and customer inspections.
• Lead product development projects from concept to commercialization.
• Coordinate with QA, QC, Production, Engineering, Procurement, and Regulatory Affairs.
• Monitor project timelines and development milestones.
• Manage resource allocation and budget for development activities.
Experience
• 15–20 years of experience in sterile injectable formulation development.
• Minimum 5–7 years in a managerial role.
• Experience in liquid injections, lyophilized products, and ophthalmics preferred.
• Exposure to regulated markets (USFDA, EU, MHRA, GCC, ROW).
Technical Skills
• Sterile formulation development.
• Lyophilization cycle development.
• Technology transfer and scale-up.
• QbD (Quality by Design) concepts.
• Risk assessment tools (FMEA).
• Statistical data analysis.
• Regulatory dossier support.
• cGMP and Data Integrity compliance.

📌 F&d Head Sachana (India)
🏢 EaseBiz Fintech Solutions
📍 India