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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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Reporting to the Executive Director of Analytical Development and Quality, the Director of Quality Control provides leadership of a scientific team that will execute the development and management of analytical assays related to AAV-based gene therapy programs.
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Automate sample preparation methods for GMP release of AAV or lentivirus gene therapy drug products. The incumbent will collaborate very closely with our Genomic Medicine Bioprocess Analytics, Characterization and Analytical Development groups, based in Framingham and Waltham MA. The applicant must have strong industry experience in developing automated liquid handler methods for common DNA/RNA sample prep workflows on Hamilton and/or Tecan platforms.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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REGENXBIO is seeking a highly motivated Upstream Manufacturing contractor to establish REGENXBIO's 1 internal GMP BDS and FDP clinical and commercial AAV gene therapy manufacturing capability. Experience with AAV manufacturing/viral transfection.
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Work with a team of multidisciplinary scientists to deploy gene editing (such as base editing and prime editing), delivery (such as AAV), and protein evolution technologies developed in the lab.
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We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products.
$104,000 - $125,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Execute routine analytical tests and quality control assays, such as qPCR, ELISA, SDS-PAGE, Western blot, and HPLC, to assess the purity, potency, and safety of AAV vector products. The Hearthis the home ofa custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.
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We will use multidisciplinary approaches including cell culture and both acute (AAV-injected) and chronic mouse models of Alzheimer’s disease. Memphis boats attractions, including Elvis Presley's Graceland, the Memphis Grizzlies, historic Beale Street, the National Civil Rights Museum, the second-largest urban county park in the United States, and the Memphis in May World Championship Barbecue Cooking Contest.
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Investigate mechanisms of AAV gene therapy. Comply with IACUC standards of in vivo research. Investigate mechanisms of AAV gene therapy. This position entails a heavy emphasis on rodent handling, working cross functionally, maintaining SOPs and experiment records, while supporting vivarium operations.
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Highly experienced in developing and implementing assays for Quality Control testing and characterization of drug substance, drug product and manufacturing in-process samplesExperienced in multiple modalities AAV gene therapy, oligonucleotides and small moleculesProficient in cGMP’s and pharmaceutical industry procedures and regulationsHighly experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations.
$289,850 - $392,150ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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We encourage applicants with strong expertise in AAV gene therapy, experience with IND submission, and particularly those with PharmD or PhD, to apply. Rocket Pharma is seeking an experienced and highly motivated Associate Director, Regulatory Affairs (USL f or AAV), who enjoys a fast paced, dynamic work environment at the forefront of innovation.
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By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to bring to our patients. Lead CMC quality execution of all CMC regulatory activities for biologics/gene therapy product development according to business priorities.
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Support method development, transfer and qualification/validation activities associated with the cell-based potency assays for AAV-based gene therapy products. The successful candidate will have hands-on experience with cell-based in-vitro potency assays, SDS-PAGE, Automated Western blot assays, enzyme activity measurements, protein extraction, purification, and quantification methods.
$72,000 - $90,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Our Vector Program group, including Manufacturing Sciences and Technology (MS&T), Analytical Sciences and Technology (AS&T) and External Manufacturing (EM) teams, provides Chemistry, Manufacturing and Controls (CMC) support for basic, translational and clinical research for adeno-associated virus (AAV) vector-based therapeutic products.
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Working within Fractyl’s Gene Therapy Research Team, the Sci II / Senior Scientist will be integral to the discovery and development of next generation AAV-based gene therapies for the treatment and cure of diabetes, obesity, and other metabolic diseases.
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