Research Scientist
3 days ago
Assist in the execution of formulation and process technology transfers from R&D to manufacturing sites (in-house and CMO).
Conduct scale-up and exhibit batches under supervision, ensuring proper documentation and parameter tracking.
Support in the preparation and review of Batch Manufacturing Records (BMRs) and validation protocols/reports.
Coordinate with R&D, QA, QC, Regulatory Affairs, and Manufacturing teams for effective knowledge transfer and execution.
Participate in process investigations, troubleshooting, and deviation handling during trial and validation batches.
Assist in equipment selection and capacity assessment based on product-specific requirements.
Ensure document readiness for regulatory submissions, respond to technical queries, and support audit preparation.
Support internal and external/vendor audits by providing required documentation and technical inputs.
Contribute to continuous improvement initiatives and support knowledge-sharing activities within the MSTG team.
Prepare data summaries, technical reports, and presentations as per project or management requirements.
Maintain accurate records, follow applicable SOPs, and ensure strict GMP compliance in all operations.
Qualifications Qualifications & Skills
B.Pharm / M.Pharm in Pharmaceutics or Pharmaceutical Technology.
2–5 years of experience in formulation development, MS&T, or technology transfer.
Exposure to solid orals, liquids, or softgel capsule dosage forms.
Understanding of scale-up principles, equipment functionality, and validation practices.
Familiar with regulatory expectations (USFDA, EU, etc.) and cGMP standards.
Good communication, documentation, and teamwork skills.
Willingness to travel to manufacturing sites as per project requirements.
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