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Extensive experience in late phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China. Lead and/or support activities for pharmaceutical profiling, phase appropriate formulation development, and drug product manufacturing of the new chemical entities of RevMed during preclinical assessment and throughout clinical development phases.
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Clinical data management systems - eCOA, IRT, and industry wide thesauri, such as MedDRA and WHO Drug. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein.
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Deep understanding of the biotech landscape, including drug discovery, RNA therapeutics, and cell therapy. We are seeking a dynamic and experienced President to lead our early-stage startups focused on drug discovery, RNA therapeutics, and cell therapy.
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We’re hiring a Product Marketing Manager who can think strategically about how to win our market and then quarterback projects that lead us to success. Ensure all relevant teams are kept informed of product activities through internal communications and/or trainings.
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Strong understanding of science and drug development, with specific expertise in nonclinical study design, preclinical CROs, data management systems, nonclinical study procedures, and statistical analysis methods.
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As a Scientist in the medicinal chemistry group at Hexagon Bio, you will work closely with the natural products chemistry and biology teams to launch new drug discovery projects and have the opportunity to serve as a functional area project leader from project initiation through investigational new drug (IND) filing.
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Product & Platform Development: Lead product discovery for our product and platform development work, collaborating closely with internal teams to define requirements, prioritize features, and ensure timely delivery of high-quality storage solutions; develop and execute a clear and executable product roadmap.
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Albertsons Companies is a leading food and drug retailer in the United States. Leaders invested in your training, career growth & development. The Company operates stores across 34 states and the District of Columbia with 24 banners including Albertsons, Safeway, Vons, Jewel-Osco, Shaw's, Acme, Tom Thumb, Randalls, United Supermarkets, Pavilions, Star Market, Haggen, Carrs, Kings Food Markets and Balducci's Food Lovers Market.
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Proven experience in the integration and management of PDM, and PLM systems for the product development life cycle within a manufacturing or engineering environment. Manage Product Build Documentation including Operations Methods Sheet (OMS) creation and Redlines, Master Layout (MLO) Creation, and maintenance of the master model.
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Manage manufacturing activities for viral vector and cell therapy, including cGMP aseptic qualification, in support of manufacturing and formulation of viral vectors as drug substance and of cell therapeutics as drug products.
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Albertsons Companies Inc. has always been a people-oriented business, and thoughtful people practices remain a core element of our company’s philosophy. Albertsons Companies is committed to bringing people together around the joys of food and to inspire well-being by transforming the grocery and pharmacy-health experience for our customers.
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Adverum is looking for an Associate Director / Director, Head of Drug Product Process Development (Drug Product PD) to join the Technology Development team at our Redwood City, CA office.
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Utilize analytical instrumentation (NMR / HPLC / LCMS) for product analysis and characterization. Possess effective purification skills to ensure the product purity and quality. Proven scientific and technical ability to design and execute synthetic route, product purification, optimization of chemistry, and analysis and present data.
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Description As a Director, Global Regulatory Affairs, Precision Medicine you will develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional stakeholders across the Gilead therapeutic areas and in compliance with the appropriate regulations.
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Bristol Myers Squibb currently markets a product in Neurology and plans to re-enter the Psychiatry market with a focus on patients suffering with schizophrenia. - Conducts in-office presentations (e.g., lunch and learns) and discusses product-related scientific information with HCPs that is consistent with label.
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product drug jobs Title: development director Company: Omeros in Redwood City, CA
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