Bioassay Development Lab
3 days ago
At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.
About the Role:
Relevant experience in biopharmaceutical industry in proof-of-concept studies, bioassay method development/ qualification/ transfer, stability sample testing, CQA assessment, biosimilarity analysis of monoclonal antibodies, insulin analogues, pegylated proteins, antibody-drug conjugates, therapeutic peptides.
- Knowledge on ICH, USP and WHO guidelines, systems biology, and its relevance to drug development in biopharmaceutical industry.
- Proficiency with aseptic technique of handling tissue culture model.
- Thorough understanding of cell culture and hands-on experience with in vitro bioassay techniques and their applications in cellular signalling, receptor binding, cytokine secretion, cell proliferation, cytotoxicity, antibody effector function and immune assays.
- Experience with novel technologies ( including but not limited to HTRF/AlphaLISA, Luminescence, ELISA, Flow Cytometry, SPR, BLI)
- Proficiency in handling instruments like (Plate Reader, Flow Cytometer, Biacore, Octet) and familiarization with 96, 384 well formats of assay
- Independently design, execute and record experiments in electronic lab note-book (Labware-LIMS) following ALCOA principles.
- Interpret and analyse data using relevant instrument software, and disseminate results through reports, data presentations in team meetings. Able to troubleshoot critical issues and determine possible solutions.
- Maintain instruments in coordination with operations team and support installation of new instrument. Keep track of ordering and maintaining inventory of consumables/ reagents and support in lab maintenance.
- Familiarity with statistical tools (GraphPad Prism, JMP), Document Management System (DMS), Digital Quality Management Software (Trackwise) is desired.
- Author or review documents including method development reports, protocols (qualification /transfer/ study) and reports (qualification /transfer/ study). Prepare operating procedures (IOP, EOP, SOP) and author change controls, deviation and CAPA
- Work primarily as an individual contributor and train and cross-train colleagues towards experimental design, execution, and troubleshooting; technical review of raw data.
Education & Experience - Post-graduate with 6-12 years of experience or PhD with 1 - 2 years of experience in biopharmaceutical industry. Life sciences background in biochemistry, biotechnology, or allied subjects preferred.
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