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ElevateBio is looking for a Cell Therapy Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events.
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Responsible for all quality aspects in collection of cellular products to support clinical trials (INDs) and external study sponsors. Reviews SOPs, policies, change controls, corrective and preventative action plans, and engraftment/outcome data related to clinical trials and investigational products along with the research RN and compliance officer.
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Expertise in biomarker discovery and development, including proficiency in molecular and cellular techniques, genomics, and bioinformatics. The successful candidate will play a pivotal role in advancing the pipeline from preclinical stages through clinical development, leveraging their expertise in translational medicine, biomarker development, and oncology/immunology.
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Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.
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Collaborate with administrators and clinical staff on continuous improvement of the MGH Cellular Therapy program and standards of practice in health care delivery. The MGH Cellular Therapy program seeks a dynamic and experienced Patient Navigator & Community Liaison to provide and oversee case management services for patients receiving primary and specialty care within the Cell Therapy Clinic.
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Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology. Work with and lead project teams to prepare clinical documents, including but not limited to protocols, CSRs, and IBs to support drug development.
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Founded in late 2015, KSQ is a clinical-stage biotech that has rapidly advanced the field of CRISPR-enabled functional genomics, from in vitro cell autonomous screens to more complex genome-scale screens of immune cells in vivo.
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Test methods include, but are not limited to molecular (SSO, SSP, SBT, NGS) and serologic typing, flow cytometry, cellular methods and complement dependent cytotoxicity. Oversee execution of high quality, reliable and cost-effective clinical HLA testing services.
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BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.
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For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. As a member of the Miltenyi Biotec Team, you will be responsible for our full line of clinical reagents, instruments and services focusing on biopharma clientele.
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We have conducted the first successful OTOF gene therapy clinical trial in children born with complete hearing loss, with the restoration of hearing and speech capability (Lv et al., The Lancet, 2024.
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Description At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. For more than 25 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy.
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Working independently, under the general supervision of senior personnel, the Research Associate will perform highly specialized experimental procedures involving in vitro protocols, advanced molecular genetics, and cellular biology techniques.
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Clinical research in Dr. Hamrah’s laboratory is focused on using live imaging - in vivo confocal microscopy - to better understand molecular and cellular mechanisms in corneal immunology, neuro-immunology and inflammation.
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The Pharmacy Department is recruiting for a Clinical Specialist to support inpatient cellular therapy, medical oncology, and hem/onc consult services. Updates clinical guidelines and presents hospital wide educational initiatives.
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cellular clinical jobs in Cambridge, MA
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