Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Biocon Pharma Ltd
Designation : Senior Scientist
Function : R&D
Functional Area : Analytical R&D
Job Role Summary : Analytical development, method validation, method transfer
Job Profile :
  • Development of analytical methods using LC-MS for Large molecules (peptides and oligonucleotides), data processing, interpretation and report preparations. 
  • Drafting and/or review of sameness-characterization reports of drug substance and drug product.
  • To transfer the analytical technology and characterization methods to the manufacturing sites or CTL for regular release testing at manufacturing site internal/external.
  • To plan timely analysis of samples, compiling and tracking the comparative results.
Job Requirements :
  • 2-8 years of Pharma QC experience
  • Analytical development, Large molecules like peptides, olegonucleotides
  • Experience required on method validations/qualification as per ICH guidelines.
  • Experience on calibration & qualification of characterization instruments.
  • Good hands-on instruments and data interpretation of characterization instruments and methods (e.g., DLS, GPC, LC-MS, FT-IR, CD, SEC-MALS, Fluorescence plate reader etc.,)
Work / Job Experience : 2-8 Years
Type of Experience : To developed analytical methods, data processing, interpretation of the data, preparation and review of reports of complex products (peptides and oligonucleotides).
Academic Qualifications :

MSc

Website Linkedin Biocon Pharma Ltd

To apply for this job please visit career10.successfactors.com.