Formulation and Development Chemists
Formulation and Development Chemists
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Key Responsibilities:
1. Formulation Development & Optimization:
- Conduct preformulation studiesincluding APIexcipient compatibility and solubility studies.
- Design and develop robust and scalableformulations for tablets capsules granules and powders.
2. Process Development & ScaleUp:
- Develop benchscale formulations andscale them up to pilot and commercial batches.
- Conduct process validation and optimization to ensure batchtobatch consistency.
- Work closely with the production qualityand regulatory teams for smooth technology transfer.
3. Regulatory & Compliance:
- Ensure all formulation activities comply with USFDAMHRA WHOGMP and ICH guidelines.
- Prepare and review technical documentsbatch records and stability protocols for regulatory submissions.
- Support ANDA NDA and dossier preparation by providing formulation related data.
4. Stability Studies & Documentation:
- Conduct stability studies as per ICHguidelines and analyze product degradation.
- Interpret analytical and stability data toimprove formulation stability and shelf life.
- Maintain accurate documentation including MFRPDR and stability reports.
5. Technology Transfer & Troubleshooting:
- Assist in technology transfer from R&Dto commercial manufacturing.
Requirements
Key Requirements:
- Education: M.Pharm / B.Pharm / M.Sc.(Pharmaceutical Sciences Pharmaceutics or related field).
- Experience: 46 years in OSD formulationdevelopment (tablets capsules granules etc..
Employment Type
Full-Time
