- 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.

Education: M.Pharm

Experience: 5-8 Years in manufacturing of Commercial validation batches and commercial launch with USFDA, EU, MHRA, ANVISA requirement etc.

Technical Skills: Expertise in preparing and reviewing regulatory documents and reports, Robust understanding of data management and documentation tools,

Soft Skills: Excellent written and verbal communication skills, Problem-solving mindset and proactive approach to challenges, Ability to work independently and as part of a team, Strong attention to detail and organizational skills

📌 Senior Research Associate (India)
🏢 DIFGEN PHARMACEUTICALS PRIVATE
📍 India