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We are seeking a Senior Quality Investigation Specialist with 10+ years of experience in cell/gene therapy or biologics. 10+ years in quality investigations within cell/gene therapy or biologics.
$40 - $45 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The mission of Packgene Biotech is to accelerate gene therapy product development by providing an integrated one-stop solution including plasmid, viral vector, fill-finish and QC analytical services for the gene therapy industry.
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We are seeking an experienced Quality Investigation Manager with over 10 years of experience in managing quality investigations within the Cell/Gene Therapy or Biologics sectors. Extensive experience in Cell/Gene Therapy or Biologics is required.
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We are seeking a highly innovative scientist with expertise in virology, gene therapy, cell culture, and other biotechnology applications to join our outstanding team of development scientists.
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Cell/Gene Therapy experience preferred. Cell/Gene Therapy experience preferred. Lead a team of Batch Record Reviewers performing the following activities: Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS.
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The Investigators in this role will be responsible for executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts, and overseeing CAPA's. Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS.
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We provide biomanufacturing strategy and execution to start up and established gene and cell therapy, pharmaceutical, and biotechnology companies. Typically, a minimum of 8 years of advanced therapy, life science, pharmaceutical, or biotech experience.
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Our Gene Therapy provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.
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As the Key Account Manager, Mid Atlantic, Uro-Oncology, you will be a critical part of the customer facing team responsible for launching our new intravesical gene therapy. Ferring is on a mission to transform the treatment of bladder cancer with a novel, first-in-class intravesical gene therapy that provides patients with an alternative to bladder removal surgery.
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Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. Collaborate cross-functionally, including with Corporate Communications and Scientific Communications, to develop key messages on disease state, MOA, target product profile, etc., and to develop communications plans for future and current clinical trials.
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The focus of team efforts is often grown out of the Centers and Institutes, including the Evelyn F. and William L. McKnight Brain Institute, the UF Genetics Institute, the Powell Gene Therapy Center, and the UF Health Cancer Center.
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The successful candidate will also have a track record in the successful development and execution of Cell and Gene Therapy-based programs spanning from project inception to IND-enabling studies, with a working knowledge of later development stages, particularly CMC and toxicology, and Phase 1 clinical trials.
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