Job Description
Roles and Responsibilities
- Protein analysis by HPLC, ELISA, OD280 methods and electrophoresis methods.
- Operation of HPLC, UV spectrophotometer, TOC analyzer, gel doc and stability chambers.
- 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.
Desired Candidate Profile
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.
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.)