Senior Research Associate

- 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.