Research Associate- Analytical (Biotech)

• Will be responsible for working on various analytic aspects for product and process quality evaluation, using techniques like LC, CE, SDS PAGE, spectrometry etc.
• Thorough knowledge of HPLC based analysis of recombinant proteins is required. Viz. RP-HPLC, SE-HPLC, glycan analysis etc.
• Experience with CE based analysis is preferable
• Will be carrying out other additional analysis like SDS PAGE, Western blotting, spectroscopic assays as and when the project demands.
• Independently work on method development of proteins, qualification, transfer following ICH/USP/EP/IP guidelines, including the writing and review of protocols, transfer plans, and reports.
• Carry out day-to-day analytical work and working in co- ordination with the process teams
• Co-ordination with QC for smooth implementation of transferred new methods.
• Responsible for R&D stage product stability sample analysis
• Maintenance of equipment logs and documentation in the lab.
• Maintaining and monitoring stability of various products in Biotech.
• Responsible for preparing and maintaining lab related documents like SOP, STP stability protocols, reports, method development, qualification and transfer protocol and reports.
• Ensure data integrity and good communication practices.

Accountabilities and Responsibilities:

• Responsible for LC, CE based developments and routine analytics for product and process-based quality evaluations of recombinant proteins (mAbs, biosimilars)
• Responsible for R&D stage stability analysis
• Responsible for maintaining required documentation in timely manner

Competencies:

• Protein sample preparation techniques (Centrifugation/Concentration/Extraction etc.)
• Key Operations and troubleshooting of LC, CE systems.
• Proficiency on MS office
• Good oral and written communication
• Good team player, should be able to work in tandem with cross functional teams when required