• Assist in the execution of process technology transfers and Commercial batches at manufacturing sites (in-house and CMO).


• Conduct scale-up, exhibit batches and commercial batches under supervision, ensuring proper documentation and parameter tracking.


• Support in the preparation and review of Batch Manufacturing Records (BMRs) and commercial 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.


• 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.