- Handle formulation development activities for OSD products including tablets and capsules.
- Plan and execute formulation trials, optimization, and scale-up activities.
- Develop and optimize formulations as per product requirements and regulatory guidelines.
- Prepare and review BMR/BPR, trial protocols, reports, specifications, and other F&D; documents.
- Coordinate with Production, QA, QC, IPQA, Regulatory Affairs and other departments for product development and technology transfer.
- Conduct and monitor trials at laboratory, pilot and manufacturing scale.
- Support troubleshooting of formulation and manufacturing-related issues.
- Evaluate raw materials and packaging materials for product development.
- Participate in technology transfer and process validation activities.
- Ensure proper documentation and compliance with GMP, GLP and applicable regulatory requirements.
- Review stability data and support stability studies for developed products.
- Guide and supervise F&D; team members and ensure timely completion of assigned activities.
Required Qualifications
- B.Pharm M.Pharm in Pharmaceutics or related specialization.
- 5 to 8 years of relevant experience in Pharmaceutical Formulation & Development, preferably in an OSD manufacturing plant.
- Solid knowledge of tablets, capsules, granulation, compression and coating processes.
- Good understanding of GMP, documentation and regulatory requirements.
- Good analytical, problem-solving and coordination skills.
Preferred Candidate Candidates having experience in OSD formulation development, scale-up, technology transfer and manufacturing plant trials will be preferred.