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PhD or equivalent in biological sciences with significant experience advancing gene therapy-focused drug discovery projects into development in a pharmaceutical or biotech environment. Intergalactic Therapeutics is seeking a Vice President, Discovery Research & Biology to lead the company’s efforts in identifying, validating and rapidly translating novel and high-value ophthalmology gene therapy targets from concept into first-in-class therapeutics for ocular diseases.
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These instruments are essential tools in the research, development, and manufacturing for several key areas including Cell and Gene Therapy, Infectious Disease, Virology and Vaccine Research, Immunology, Immuno-oncology, and Immunotherapy, as well as Next Generation Sequencing, and Pre-Natal Disease Detection.
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Experience in Business or System Administrator is a plusExperience with managing vendors/consultants/partners (e.g. external publishing vendor)Strong understanding of Regulatory Operation comprehensive roleDesirablePrior regulatory operations experience in cell and gene therapy and/or oncology is strongly preferredExperience with BLAs/NDAs/MAAs preferredExpertise in Veeva RIM, system implementation experience a plus.
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Gene Therapy products, and final product fills according to current Good. biologist, biology, mammalian cell, cell culture, protein purification, aseptic, cell banking, GMP, cGMP, cell production, upstream, downstream.
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Affinia Therapeutics is an innovative gene therapy company with a vision to create a paradigm shift by broadening the reach of gene therapy to prevalent diseases. Our proprietary Affinia Rationally-designed Therapies (ART) platform was created to address key efficacy, safety, and cost of goods limitations of conventional gene therapies.
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Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring and drug product release, specifically SDS-PAGE, western blot, droplet digital PCR or qPCR, culture of primary mammalian cells, and cell-based potency assays.
$84,000 - $118,667 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.
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Familiar knowledge of GLP and GMP requirements as they pertain to protein and gene therapy process development and Quality Control (QC) testing is a plus. Leads the activities associated with the development and execution of methods relevant to protein and gene therapy products for analytical development in a Research and Development environment.
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Strategic Sourcing Associate Director, Cell and Gene Therapy Raw Materials (hybrid) page is loaded. Minimum of 7-10 years of experience in strategic sourcing, procurement, or supply chain management, with a focus on raw materials for Cell and Gene therapy or biologic in the pharmaceutical or biotechnology industry.
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This is a multidisciplinary role & this individual will further interface across many parts of the company to support novel products used in the cell and gene therapy world. We are seeking an innovative and highly motivated individual to join our team as the Manager of Quality Control at our GMP manufacturing facility located in South San Francisco, CA. This position will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products.
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Broad exposure to a wide variety of protein therapeutics (enzymes, gene & cell therapy, multifunctional therapeutic, oncolytic virus) Become a key contributor to our team as a Scientist, supporting the development and validation of PCR assays that are instrumental in bringing innovative cell and gene therapies to market.
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Provide strategic recommendations across analytical network, spanning Cell Therapy, Gene Therapy and Biologics. Serve as Subject Method Expert to facilitate the development, validation, transfer, and trending of Cell therapy flow cytometry and potency analytical methods.
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We provide biomanufacturing strategy and execution to start up and established gene and cell therapy, pharmaceutical, and biotechnology companies. Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry.
$63,000 - $75,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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What you bring: PhD in biology, biochemistry, molecular biology, gene editing, or a related discipline and at least two years of closely related gene therapy or gene editing experience OR MS degree and five years directly applicable experience.
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The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs.
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