Sr. Research Associate/Scientist

This role provides an opportunity to learn and grow as an expert in the field of analytical R&D for biosimilars and biologics.

Role & responsibilities

• Will be responsible for working on various analytic aspects for product and process quality evaluation, using techniques like cell based assay, ELISA, SDS PAGE, western blot and FACS.
• Basic understanding of biological pathways is required to design a cell based assay.
• Should be independently able to carry out cell banking process and maintain record of the same.
• Should be able to plan, execute, analyze, compile and present data to bigger/cross functional teams.
• 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 coordination 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 documentation practices

Accountabilities and Responsibilities:

• Responsible for cell and ELISA 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

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Competencies:

• Protein sample preparation techniques (Centrifugation/Concentration/Extraction etc.)
• Cell based assay and ELISA method developments and data analysis.
• 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