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The ideal candidate for this position should have work experience in cell therapy process development, manufacturing science, analytical development, and familiarity with GMP/FDA/ICH guidelines.
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Actively looking for a Senior Scientist, Cell Therapy Process Development contributing to the development of early and late stage clinical cell therapy manufacturing processes. Experience with common equipment used in cell therapy manufacturing such as Sepax, Lovo, G-Rex, Xuri Bioreactors, CliniMACs Plus, CliniMACS Prodigy, MaxCyte GT.
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The Director of Biospecimen Management for Cell Therapy & Early Oncology will efficiently and independently perform the duties and responsibilities outlined below. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
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Drives Hematology and Cell Therapy forward to achieve significant acceleration of historic time to market for Digital Projects in BMS by applying sharp prioritization, Minimum Viable Product mindset and cross functional leadership.
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B.S. in Engineering or Science discipline and 10+ years of GMP cell therapy and/or biologics/gene therapy manufacturing experience OR M.S. in Engineering in a Science discipline plus 10+ years of GMP cell therapy and/or biologics/gene therapy manufacturing experience.
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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, med ed) Subspecialty training in relevant therapeutic area preferred (Sickle Cell/Hemoglobinopathies) We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
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For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
$142,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Familiarity with cell therapy processes and cGMP is strongly preferred. Minimum 3 years relevant experience in GMP biologic/cell therapy manufacturing technical or process support. Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer.
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ProBio proactively provides 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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Serve as subject matter expert for residual DNA by qPCR, host cell protein ELISA, Residual Protein A ELISA, binding activity ELISA, Capillary Electrophoresis (CE), and capillary isoelectric focusing electrophoresis(cIEF), including qualification, assay validation and transfer activities.
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Collaborate with the full GMAx organization (Pricing, HEOR, in region teams) to holistically assess BMS' Oncology assets, maximizing both speed of access and long-term franchise value with consideration for commercial objectives and the market environment we anticipated at launch of the asset/combination of assets.
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This individual contributor role is responsible for managing task-level activities for both in-house and outsourced clinical studies, ensuring alignment with Bristol-Myers Squibb's (BMS) outsourcing strategies.
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The TS&Dx group integrates scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients and health care providers we serve.
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Cell therapy / Biotech exp. Cell therapy / Biotech exp. Job title: Business Systems Analyst. Writing test scripts as well as SOP and work instructions. SAP analyst with some IT/ Background. Experience Training internal and external end users.
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Equipment validation (bioreactor IOQ and PQ study, but not limited to the other cell culture validation activity). At least 3-5 years working in the cell culture area in the Biopharma industry.
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cell job in Hopewell, NJ
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