Bioassay Quality Specialist

4 hours ago


Delhi, Delhi, India Biocon Biologics Full time

About Biocon Biologics

We are a global biosimilars organization leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes.

Our team of ~ 4,800 people is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients worldwide. We have a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases with six molecules from our portfolio having been taken from lab to market in developed markets like the United States, EU, Australia, Canada, and Japan.

Job Summary

As a Bioassay Quality Specialist at Biocon Biologics, you will play a crucial role in ensuring data integrity culture in our Quality Control Lab and adhering to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice). You will also be responsible for qualification of analytical instruments and equipment (IQ/OQ/PQ), receipt and storage of samples, preparation and qualification of cell banks used in bioassays, planning and performing In-Process, finished product, and stability sample testing, review of analytical reports, and reporting and investigation of Incidents, OOS, OOT, and Deviation.

Responsibilities
  • Ensure Data Integrity Culture in Quality Control Lab
  • Adhere to cGMP, cGLP, and GDP
  • Qualify Analytical Instruments and Equipment (IQ/OQ/PQ)
  • Manage Samples Receipt and Storage
  • Prepare and Qualify Cell Banks Used in Bioassays
  • Plan and Perform Testing of In-Process, Finished Product, and Stability Samples
  • Review Analytical Reports
  • Report and Investigate Incidents, OOS, OOT, and Deviation
Requirements

You should have a Masters Degree in a relevant field and 2-4 years of experience in the pharma industry. Your key skills should include bioassay, cell culture, and Pharma experience.

Estimated Salary

USD $60,000 - $80,000 per year, depending on location and experience.



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