Bioassay Analyst

Core Purpose of the Role:

• Responsible to perform the development, validation, and routine testing of bioassay/ELISA for Large Molecules (LMs), especially Monoclonal antibodies (mAbs) and other LMs

Role Accountabilities:

• Shall develop and validate cell-based assays and binding assays (ELISA), especially for monoclonal antibodies (mAbs), etc. Shall troubleshoot the problems with bioassay methods
• Must have strong knowledge of the development of cell-based bioassays for Monoclonal antibodies.
• Experience in Qualification and Validation of cell-based bioassays
• Broad knowledge on analysis of cell-based assays to derive relative potency softwares (such as Softmax Pro and PLA)
• Basic cell culture technics and hands-on experience in maintaining of mammalian cells.
• Must have experience in handling various cell lines (adherent and suspension cell lines).
• Preparation of Mammalian cell banks for Bioassays. Experience in handling of primary and continuous cell lines like Revival, maintenance, cell bank preparation, and cryopreservation
• Shall prepare the raw datasheets, protocols, reports, and SOPs
• Handling of QMS (Incidents, deviations, change controls, etc.) for GMP activities
• Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares etc., required for the projects
• Shall adhere to the procedure of GxP/GMP/Safety and as per the procedure defined in the internal standard operation procedure
• Must have good hold on MS office (word, excel, ppt), outlook, and other essential tools required for routine activity
• Good communication and e-mail writing skills are required since the candidate needs t communicate with clients/external users situated overseas
• Commitment to safety