QC Analyst - CuraTeQ Biologics

Role & responsibilities

• Responsible to receive, register and analyze batch samples and stability samples.
• Responsible to prepare reagents, buffers and test solutions as and when required.
• Responsible to operate, calibrate/ verify/ qualify HPLC, UPLC instruments.
• Responsible to execute the Analytical Method validations/verifications/Transfers
• Responsible to prepare SOPs, STPs, Protocols and other GMP documents
• Responsible to interpret and record the data / results accurately and contemporaneously.
• Responsible to report to superior any abnormalities found during routine activities
• Responsible to follow Hygiene, Safety, SOPs, GLP, GMP and GDP.

Preferred candidate profile

• Adequate testing knowledge on Biologics/Monoclonal Antibodies
• Capillary Electrophoresis : CESDS-R, CESDS-NR
• HPLC : RP, SEC, Glycan, CEX, Ion exchange chromatography and Polysorbate 20
• Maurice : charge variants by iCEF
• UPLC : Peptide mapping.

Qualification and Experience :

MSc Biotechnology/Biochemistry/Microbiology with 03-07 Years experience of Biosimilars/Biologics QC.