Main purpose of the Job: Should have experience on analytical methods for Biosimilars/therapeutic proteins. Responsible for analysis, documentation of quality control activities which includes in process sample, Release samples, Stability studies sample analysis for Biological products. Job Responsibilities:
Experience on Biosimilars mabs QC analysis.
Protein analysis by HPLC, ELISA, OD280 methods and electrophoresis methods.
Operation of HPLC, UV spectrophotometer, gel doc and stability chambers.
Raw materials maintenance, preparation of specifications, CoAs.
Sample receiving, withdrawal, aliquoting and allotting A.R.No.of In -process, batch release and stability for analysis related to products testing.
Preparation of standard operating procedures, specification and standard testing procedures.
Preparation of reagents, chemicals and buffers as per the STPs
Documentation of analytical data and preparation of STP.
Responsible for compliance to cGMP practices and maintenance of chemical inventory.
Environmental monitoring for clean rooms in QC and manufacturing area.
Calibration of instruments and equipment as per the SOP.
Preparation of QMS documents like change controls, deviations etc.
Skills/Competencies Technical Skills/Competencies (experience with Analytical Technics on Biosimialrs etc.) Behavioral Skills/Competencies (e.g. excellent communication skills, strong collaborator, Problem solving etc.)
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