Job Description

Department Details
Role Summary
We are seeking a skilled professional with leadership qualities who will be involved in R&D activities of bioassay function in BBL.
Key Responsibilities:

• Design, development, optimization and qualification of in vitro cell-based assays (reporter gene assays, proliferation assays, Fc effector assays such as ADC, CDC, ADCP, cellular signalling, receptor binding, cytokine secretion, cell proliferation, cytotoxicity, other antibody effector function), binding assays (ELISA, HTRF, AlphaLISA, SPR, BLI), and flow cytometry-based assays (analysis and sorting) to support batch release, stability testing and characterization of biosimilars.
• Independently design and execute experiments for complex bioassays and perform critical sample analysis as required. Train junior colleagues on such complex tasks and review the outcome. Author study reports of critical activities such as, method development and qualification, structure function mapping, method transfer and bio similarity testing.
• Handle relevant equipment (Plate Reader, Flow Cytometer, Biacore, Octet, Gyros, Tecan Liquid Handler) to collect assay data and analyses the data with analysis software. Serve as a power user in acquisition/analysis software and create fixed protocol/templates in software to be used by junior colleagues for sample testing
• Prepare/review eLN workbook templates for methods.
• Meticulously review experiments performed by junior colleagues, ensuring data traceability, review of sample results, observations, interpretations and troubleshooting for logical closure of experiments. Regularly review trend charts and provide technical inputs.
• Review quality documents like IOP, EOP and compliance procedures like change controls and deviations Keep abreast of the latest scientific and technical updates pertinent to the timely project deliverables and plan experimentation accordingly.
• Provides quality data from comprehensively designed experiments with suitable controls, for regulatory submissions Serve as a project SPOC and work with group lead and junior colleagues to achieve project deliverables within timelines.
• Manage reference standard inventory, sample receipt, storage, allocation of analysts and timely turn-around of results. Contribute effectively towards presenting results and conclusions in cross-functional meetings
• Propose and monitor laboratory expenditure. Manage inventory of critical reagents and consumables.
• Place purchase request and do follow ups with other cross functional teams for procurement. Manages equipment/instrument allocation.
• Documentation practice and a strong understanding of ALCOA is essential and experience with electronic laboratory notebook.
• Experience of ICH, WHO, USP guidelines for development, qualification, transfer, validation and experience with electronic laboratory notebook system

Key Responsibilities
Technical Expertise:

• Cell based potency Assays (proliferation, differentiation, cytotoxicity)
• Immunology assays (T cells, MDSC, PBMC)
• Flow Cytometry (sorting and analysis)
• Enzyme-linked immunosorbent assay (ELISA)
• Biolayer Interferometry (BLI) Surface Plasmon Resonance (SPR) Analysis (end point and kinetics

Educational Qualifications
Required Education Qualification: M.Sc
Required Experience: 9 - 12 years

Skills Required