Nancy Patel

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Responsible for the completion of in-process, release and stability QC testing related to the manufacturing of CGT products in a controlled cGMP cleanroom environment. Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations. Work with Process Development/Analytical Development/ Manufacturing Science & Technology team, Quality and Operations to successfully transfer analytical testing to cGMP facility. Conduct analytical testing of raw material/reagent samples submitted to the QC laboratories. Perform review of laboratory data Create, review and approve relevant QC documents, Standard Operating Procedures, Work Instructions, Analytical Testing Methods, and Forms Perform assigned tasks within a CAPA, Deviation, CC or other quality-driven projects. Communicate effectively with management regarding task completion, roadblocks, and needs. Participate meetings, to provide input on timelines, potential compliance issues and other related QC activities.

Execute and perform testing as per methods independently, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines, Keep all records and notebooks in good order, Prepare reports and record data in timely manner, Maintain up to date work order documentation and complete work order documentation in every respect before submission to the Department Manager/Group Leader to ensure valid outcome/results, Conduct routine instrument checks for compliance and accurate testing results. Perform calibrations and qualifications as required. Record accurate findings/usage in logbooks, Ensure that work order documentation is complete in every respect and all results are entered into Electronic Laboratory Information System or client’s Certificate of Analysis before submission to the QA reviewer, Maintain clean and organized workbench area ensuring spills are immediately cleaned; disposal is according to laboratory procedures; glassware is appropriately handled, and lab solutions are replaced, Assist Group Leader/Manager to prepare method SOP, validation protocol and validation report, and perform validation experiments, Assist Group Leader/Manager to trouble-shoot test methods/instruments, Ensure that equipment is maintained in good order; perform calibrations and qualifications as required.

Ensures that all samples are properly labeled and identified before testing. Follows established protocol for the handling of unsuitable samples. Operates complex instruments following department procedures. Ensuring all inquiries and problems are handled in a courteous and professional manner. Performing routine equipment maintenance following documented procedures. Documenting all maintenance performed, including minor troubleshooting following manufacturer’s instructions. Ensured all quality control checks and standards are maintained

Media preparation, working with food samples, pipetting and plating the samples for detection of food pathogens, maintaining records of the results for quality control purposes, using BAX system, receiving food samples and logging the samples into the systems, autoclave operation, quality control studies, WHIMIS training and fire safety program, working in the post incubation, pre incubation, media preparation and as a customer service representative. Performing daily instrument checks and logging the data in data sheets.

Project: Isolation of Anti-Quorum sensing substances producing compounds from Tobacco phyllosphere and rhizosphere and its effect on Pseudomonas aeruginosa Maintaining the bacterial cultures, primary cell lines, prepare the media in large amounts, preparation of reagents required in laboratory, protein purification, PCR, immunocytochemistry preparation of agarose gel and gel for SDS PAGE, microscopic analysis of bacteria and fungi, bioinformatics analysis of proteins using NCBI BLAST, maintaining daily data logs for incubators, refrigerators, shakers, etc and reporting any defects, write research reports and thesis for ongoing experimental projects in lab