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Authors, reviews, and assists with submission of CMC documentation for INDs, IMPDs, BLAs and MAAs for cell and gene therapy programs. Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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Manages symptoms/toxicities/health abnormalities related to the intense high dose therapy, stem cell rescue and rehabilitation following rescue in collaboration with transplant physician and/ supervisor.
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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. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
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With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics) to help address unmet clinical needs in a host of hematological cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death.
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Loma Linda University Medical Center is the major and only Academic Medical Center in the Inland Empire in Southern California that provides Transplant and Cell therapy. Teaching responsibilities would involve oversight of residents, fellows, and mid-level providers during ambulatory and inpatient activities, The TCT Division is focused on the development and implementation of novel cell-based and immune therapies (including CAR-T, vaccine, and gene therapy) as well as autologous and allogeneic hematopoietic stem-cell transplantation.
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Process Development Engineer, Cell Therapy. This position is an invaluable opportunity to gain experience working with cutting edge technology and a variety of cell types that are significant to the rapidly emerging cell and gene therapy market.
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Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking an Executive Director, Medical Affairs who will be instrumental in creating and building the global medical affairs function at Precigen for our first commercial launch.
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Experience in Gene and Cell therapy is desirable. Hands-on experience and In-depth knowledge of in-vitro cell-based potency assays. Experience with NGS is a highly preferred skill (e.g., Illumina, nanopore, next seq, nova seq, hi seq, SMRT sequencing, Sequel, HiFi sequencing etc.
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Key Responsibilities The Medical Science Liaison (MSL) is a member of a field-based team of scientists who function as an extension of the US Medical Affairs organization. MSLs provide medical information through scientific exchange in a fair-balanced manner and provide clinical/scientific support for Bristol Myers Squibb and the Medical Affairs department at the direction of Medical Affairs management.
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Reporting to the Head of Cell Therapy Analytical Development and Operations, you will be a vital link between Analytical Development, Process Development Pilot Plant, and the broader Novartis Operations team.
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This individual will be instrumental in managing patient scheduling master data for a rapidly growing Cell Therapy portfolio, enabling a best-in-class customer experience for our patient treatment centers around the world.
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Knowledge of GMP and regulatory requirements applicable to cell and gene therapy drug products. Develop sensitive and robust analytical test methods to support release testing, stability and characterization of investigational cell therapy drug products.
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WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies.
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We seek a Cancer Clinical Research Coordinator Associate -Blood and Marrow Transplantation & Cell Therapy (BMT-CT) to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach.
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The Research Associate will be part of Century’s Immunology / In-Vitro Pharmacology team focused on executing various assays to assess the functionality and fitness of our iPSC derived cell therapy products.
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