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Experience with cell and/or gene therapy analytical technique (e.g. flow cytometry, qPCR). It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
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Additionally, will provide input in the development & execution strategy of Preventative Maintenance (PM) & Predictive Maintenance (PDM) practices to ensure compliance (GMP and PSM) with company policies and appropriate regulatory standards.
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Work on other highly complex clinical systems related to the Proton Therapy System, including Motion control systems, CT Scanners, X-ray and Radiological technology devices and robotic manipulators directly at the customer site.
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Experience in molecular biology (gene engineering and cloning, analytical purification of nucleic acids in agarose and polyacrylamide gels, The Assistant Research Professor in the Department of Genetics will work with Professor Schindler and Jains’ research groups to carryout interdisciplinary research in molecular genetics and cell biology using mouse.
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Test raw materials, In-process, extended release Intermediates, Finished Product + Stability samples, incl dissolution, assay, preservatives, Related Compounds analysis, content/blend uniformity, particle size distribution by Laser Diffraction/Sieve Analysis, Bulk + Tapped density, cleaning verification/validation according to analytical methods, United States Pharmacopeia (USP) procedures in GMP-regulated lab environment.
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10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC.
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GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers.
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Executes experiments and analyzes data from flow cytometry analytical assays with limited supervision, as part of the Cell Therapy Analytical Development (CTAD) team. Experience working in a regulated (GLP/GMP) environment in preferred.
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The Primary Therapist is responsible for performing client care, provide group therapy, treatment planning, and coordinating discharge planning. Primary Therapist - Mental Health. LPC, LAC, LSW, LMFT, LCSW with active clear license or certification in good standing.
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Leads production activities for a personalized cell therapy, supporting both clinical and commercial requirements in a sterile Good Manufacturing Practice (GMP) environment. Learn more at Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy.
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Experience: - Proven track record in cellular immunotherapy, particularly in CAR-T cell therapy and gene therapy. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program.
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This role will be responsible for developing and maintaining standards that support GMP Manufacturing systems that are in alignment with GMP quality policies and procedures. Interface with peer Tech Leads and leadership in Corporate Infrastructure & Security (CIS) to implement GMP-compliant technical solutions that meet standards.
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CGMP manufacturing experience, preferably cell/gene therapy, with experience in tech transfer, process validation, project management, and change management. Cell/Gene Therapy and CDMO experience preferred.
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This role supports Cell Therapy Financial Planning & Analysis function. - Support in the standard cost setting process for externally manufactured cell therapy products including updating system with new standards.
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Specialist, QA Operations, is responsible for quality oversight of Cell Therapy Development Operations (CTDO) activities in accordance with Client policies, standards, procedures, and Global cGMP requirements.
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gene therapy gmp jobs in Somerset, NJ
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