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Must have direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies, with a demonstrated track record of significant accomplishments (e.g. successful IND, leading health authority interactions on CMC topics.
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The individual in this role will collaborate closely with research, process development, manufacturing, regulatory, and quality to develop and innovate Vertex next generation Cell and Gene Therapy products.
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Stay current with industry trends, emerging technologies, and regulatory guidelines related to viral vector formulation and gene therapy. Knowledge of biopharmaceutical manufacturing processes and regulatory requirements for gene therapy products.
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Job Title: Postdoctoral Fellow Location: Cambridge, MA Duration: 12 months on Contract Description: Highlights: Strong Molecular Biology Description The Biological Process Development recently has Cell Line Development (CLD) group is responsible for producing cell lines that express clinical grade therapeutic proteins and viral vectors for Cell and Gene Therapies.
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The Chief of Staff for Pharmacy will work on major projects to help lead and support BMC Hospital pharmacy including inpatient, ambulatory, specialty pharmacy, advanced therapies / bio-engineered products (e.g. cell therapy program, gene therapy programs etc.
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We are looking for a highly analytical, self-motivated, and solution-oriented Biostatistician II with experience and interest in oncology and/or molecular data to join our Tempus Discover team supporting Medical Affairs.
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Understanding of raw material specifications, quality requirements, and regulatory standards relevant to cell and gene therapy manufacturing. Cross-functional Collaboration - Work closely with cross-functional teams, including R&D, external manufacturing, quality control, vendor quality and regulatory affairs, to align sourcing activities with production schedules, product specifications, and regulatory requirements.
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You will play a key role in the design and oversight of nonclinical studies in discovery stages and in early preclinical development of gene therapy product candidates for inner ear disorders. Expertise in cochlear and auditory function test outcome interpretation, e.g., auditory brainstem response and distortion product otoacoustic emission testing.
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Work closely with other departments, including Commercial, Medical Affairs, Regulatory, and Legal, to align market access strategies with broader business objectives. The Vice President of Market Access and Public Policy will lead the strategic development and execution of market access and public policy initiatives to ensure the successful launch and sustainable patient access of our innovative gene editing medicines in both ex vivo and in vivo applications.
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The Assistant Vice President for Institutional Effectiveness will translate complex data into actionable insights, thereby empowering various departments, including academic affairs, student affairs, student services, finance, and facilities, to make data-driven decisions.
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Our Engenious gene therapy platform is the first to precisely engineer any or all hematopoietic and immune cells with a one-time, off-the-shelf in vivo treatment. Experience with Preclinical to Phase 2 stage product development with Gene and Cell Therapy products.
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Coordinate with cross-functional process development, analytical development, gene editing, and preclinical teams to perform matrixed evaluations of RNA constructs. We are seeking a Scientist, RNA Technology to join a team focused on design and optimization of RNA for Verve’s novel CRISPR gene editing therapies.
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Proven expertise in molecular biology assays such as gene expression analysis, Western blot, flow cytometry and histological techniques as well as assays relevant to pancreatic research to assess islet purity (e.g. DTZ staining), viability (e.g. metabolic and apoptosis assays), and function (e.g. GSIS.
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Ensoma is supported by top-tier investors, a strategic collaboration with Takeda and a passionate team committed to a bold global vision for gene therapy. We believe the future of medicine lies within us – and this bigger, bolder vision for gene therapy needs incredible people to make it a reality.
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Working closely with the Regional Account Managers, Inside Sales Representatives and Marketing, you will leverage your strong technical background and consultative training and support experience to establish and maintain relationships with new and existing clients in the life science sector (BioPharma, Biotech, CRO/CDMOs, etc), with a focus on Single Cell and Proteomic applications within the areas of Cell Line Development, Antibody Discovery, Bioprocessing, Cell & Gene Therapy, and more.
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consumer affairs gene jobs Title: regulatory affairs in Boston, MA
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