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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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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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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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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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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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A minimum of 10+ yrs hands on experience in Process Development of cell therapy and/or gene therapy products. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
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Represent Analytical Development on cross-functional gene therapy CMC development teams. Ph. D. in biochemistry, biophysics, chemistry or other related scientific discipline with 8+ years of industry experience in analytical development for biologics and gene therapies (an equivalent combination of education and experience may be considered.
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Scientist I - Immunology - Gene Therapy Research Sarepta Therapeutics is seeking a motivated and creative individual to work in a key drug discovery group in our research organization and play a central role in gene therapy drug developme.
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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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Maintain compliance with applicable regulatory requirements for cellular and gene therapy products. We are immediately hiring for an Entry-Level Laboratory Technician in the Gene Therapy field.
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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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The candidate will perform literature search about the newest trend and technology in Cell and Gene Therapy development, majorly focused on finding a way to make stable inducible host cells line to product viral vectors.
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Experience of working with multiple modalities ideally small molecules, ASOs, gene therapy, cell therapy and biologics. Reviews and approves regulatory documents and correspondence on behalf of DMPK.
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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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affairs gene therapy jobs Title: regulatory affairs in Anoka, Minnesota
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