Education : Less Than High School Description : Job ID 223306BR Posting Title QC, Scientist CAR-T Cell Division Novartis Technical Operations Business Unit NTO BTDM Country USA Work Location Morris Plains Company/Legal Entity Novartis Pharmaceuticals Functional Area Quality Job Type Full Time Employment Type Regular Job Description The position shift is Sunday-Wednesday OR Wednesday-SaturdayNovartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Novartis recently received the first ever FDA approval for a CAR-T cell therapy, Kymriah, for children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a novel immunocellular therapy, a one-time treatment that uses a patient's own T cells to fight cancer, and is the first therapy based on gene transfer approved by the FDA. Kymriah will be manufactured for individual patients using their own cells at the Novartis Morris Plains, New Jersey facility where Novartis continues to advance its CAR-T manufacturing expertise. The Morris Plains site plans to hire over 300 Quality, Production, Supply Chain and Bioanalytics associates in the next 10-12 months.This position will be 2nd shift either Sunday-Wednesday OR Wednesday-Saturday. Perform Micro/EM testing such as, but not limited to, environmental monitoring, Gram stain, sterility, endotoxin, and mycoplasma.* Perform all testing and activities compliantly following appropriate SOPs and Work Procedures.* Perform logbook reviews and monthly laboratory cleaning.* Maintain controls and reference materials to support testing.* Enter/review data in LIMS.* Review QC documents to ensure completeness, accuracy, consistency and clarity.* Generate and analyze trend reports.* Review reports that are generated and makes conclusions as to any action required based on the data.* Manage assigned projects.* Develop and revise documents to support process efficiencies and to maintain compliance.* Initiate change controls.* Maintain the gowning qualification program.* Train lab personnel.* Identify and execute process improvements* Lead and/or participate in investigations/CAPAs.* Support 5S and Lean Lab projects.* Interface with QA and regulatory agencies during audits.* Working knowledge of LabWare LIMS and/or other QC data systems.* Working knowledge of appropriate GMP quality systems (e.g. eSOPs, TEDI, etc.).* Perform other job duties as assigned. EEO Statement Minimum requirements EducationEducationBS, MS or advanced degree in Biology, Chemistry, Biochemistry, Microbiology or other related scienceExperience3-8 years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, cell and gene therapy, or medical device industry.Working knowledge of aseptic manufacturing, cGMPs, GLPs and applicable compendial and regulatory guidelines (e.g. FDA, EP, JP). Thorough knowledge of microbiological test methods and environmental monitoring programs. * Experience with LIMS. Strong written and verbal communication skills. * Detail-oriented with expertise in problem solving and solid decision making abilities. Strong interpersonal skills.The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. County : Morris Primary Phone : 8627781001 Fax Number : 8627781001 Email : sangeeth.jayanthan@novartis.com URL : http://ipc.us/t/50472F81F45444A9