Source description
About the role
- 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 & Skills - B.Pharm / M.Pharm in Pharmaceutics or Pharmaceutical Technology. - 25 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. - Valuable communication, documentation, and teamwork skills. - Willingness to travel to manufacturing sites as per project requirements. - 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 & Skills - B.Pharm / M.Pharm in Pharmaceutics or Pharmaceutical Technology. - 25 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. - Valuable communication, documentation, and teamwork skills. - Willingness to travel to manufacturing sites as per project requirements.