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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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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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Regional Scientific Director, Gene Therapy/Cardiovascular (Midwest) TMAC (The Medical Affairs Company (TMAC. The RSDs will set the standard for a new class of medicine and educate PIs, Centers of Excellence, KOLs and institutional healthcare disciplinary teams thus optimally enabling them to harness the full potential of the company’s CRISPR-based, first-in-class gene editing platform and delivery technologies.
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As a postdoctoral researcher at the Center for Embryonic Cell and Gene Therapy of Oregon Health & Science University, this position will work in the area of gene therapy on development of various genome editing approaches and their delivery into target cells and tissues in vitro (human) and in vivo (mouse.
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2 years of experience understanding genetic mutations and their impact on the biological functionality of proteins, experience with genetic medicines including gene-therapy, gene-editing, cell therapy, mRNA and RNA silencing experience with pharmacokinetic, pharmacodynamics data and safety data.
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The applicant should be well trained and have extensive experience in microbiology/handing bacteria (especially ; molecular biology (designing gene constructs, DNA cloning, PCR), and fluorescence microscopy.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Regulatory Affairs Specialist.
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Washington DC, Department of Consumer and Regulatory Affairs, Board of Industrial Trades, Class 1 – Steam Engineer License MD, Class 1 – Steam Engineer License. Ten (10) years’ experience as a mechanical engineer or journeyman mechanic with field experience in either maritime or industrial plant (construction, operation, or maintenance) as well as one of the following licenses: National Institute for the Uniform Licensing of Power Engineers, Inc. (NIULPE) First Class Power Engineer License.
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Serve as initial contact for Antitrust student fellows and students completing the Competition and Consumer Protesting Law Certificate Program on student affairs matters. Duties and Responsibilities Job Summary:Loyola University of Chicago is seeking a Program Coordinator to provide broad based programmatic and administrative management for its nationally prominent Institute for Consumer Antitrust Studies, as well as administrative support to a cohort of Law School faculty and programs.
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The Student Affairs portfolio includes but is not limited to, the VPSA Office, Dean of Students Office, Center for Student Leadership and Engagement, Fraternity/Sorority Life, Office of Community and Ethical Standards, Campus Recreation, Office of Advocacy and Success, Student Health and Wellness Services, Campus Reservations and Events, Student Affairs Business Operations, Military and Veteran Engagement, Residential Living and Resident Learning.
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Biopharma CGT (Cell and Gene Therapies) is seeking a Senior Manager of Materials Operations to lead a team responsible of multiple GMP warehouses within Vertex’s internal Cell and Gene Therapy manufacturing network.
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These programs may include HACCP, HARPC, Global Food Safety Initiatives (SQF, BRC) Certification, Alchemy Training, Metrics/KPI's, Environmental, Foreign Material, Pest Control, Consumer Affairs, USDA, FDA, Tracking, Trending and other FSQA procedures.
$75,000 - $85,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Job Description Montgomery College, Office of Student Affairs, Central Services, has an immediate need for a full-time Student Affairs Office Operations Director. The Student Affairs Office Operations Director provides leadership support to the Senior VP by overseeing operational and administrative functions of the Senior VP’s office; managing and analyzing the budget; and performing strategic planning.
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Deliver impactful outcomes by leveraging a deep understanding and experience in navigating typical workflows within drug discovery, drug development, gene-to-antibody, and proteomics. Familiarity with most common Sequencing, Synthetic Biology, cell and gene therapies, and molecular biology lab techniques.
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consumer affairs gene jobs Title: regulatory affairs in Anoka, Minnesota
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