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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
$221,170 - $286,220 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Director of Formulation & Drug Product Development. The responsibilities will be primarily to develop analytical methods and biophysical characterization assays, perform routine testing in support of formulation development and work with CRO/CMO for Drug Product analytical method tech transfer.
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Extensive experience in late phase innovative drug development and commercial launch with global CMC regulatory filings (IND/NDA/MAA, etc.) Thorough understanding and working experience of innovative drug development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements.
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Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
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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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Licensed Clinical Drug and Alcohol Counselor (LCADC) is preferred. As a Director of Clinical Performance Improvement, you will oversee and maintain comprehensive and effective clinical process improvement systems for Pinnacle Treatment Services.
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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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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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In collaboration with the Analytical Development function, provide quality oversight for GMP activities including, approval of Method Validation, Specifications, Release testing, and Stability for Drug Substance and Drug Products.
$135,000 - $175,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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A basic understanding of formulation and drug product process development for biologics (antibodies, fusion proteins, bi-specifics, vaccines, antibody drug conjugates, etc. Description: 100% onsite - Oceanside, CA Pay Rate: $45.00 Role: Senior Research Associate - Biologics Drug Product Development (BDPD.
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Lead purification process development and transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate. Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and authored CMC sections in commercial filings (BLA, MAA) and post approval changes.
$237,660 - $307,560ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Genesis Therapeutics is building a world-class software team to solve problems in drug discovery through machine learning, biophysical simulation, and computational chemistry. A world-class, tight-knit team of good-hearted people across software, machine learning, computational chemistry, medicinal chemistry, and biology.
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The mammographer is required to be completely familiar with, and adhere to, all U.S. Food and Drug Administration (FDA) guidelines regulating the practice of mammography, radiation safety, and quality assurance requirements.
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Demonstrated in-depth knowledge of drug development, from preclinical to late-stage development, including experience submitting BLAs and MAAs to the FDA and EMA. Reporting to the SVP, Product Strategy & Commercialization, the Vice President, Global Program Team Leader (PTL) will be responsible for leading the cross-functional strategy team for one or more development candidates.
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drug job Title: development director Company: Omeros in San Carlos, CA
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