Senior Research Associate

Job DetailsJob Location: DifGen Pharmaceuticals Pvt Ltd- R&D - Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072Position Type: Full TimeJob Shift: Day
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.

QualificationsEducation: 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, Strong 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