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Evaluate and develop the most appropriate biochemical and biophysical characterization tools to support biological drug product development, including adjuvanted vaccine drug products.
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The Biologics group is responsible for various functions criticalfor drug development such as: antibody discovery, molecular biology, cell line engineering,protein engineering, biophysical analytics, and functional cell assays.
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Lyophilization cycle development, GMP drug product fill and finish, lab automation and data science experience and expertise is highly desired. Extensive experience with formulation development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats; experience of IND filings.
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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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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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Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions (such as Drug Product Development, Drug Substance Development, Analytical/QC, and Quality teams.
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This role is in the Analytical Development & Operations (ADO) group within Technical Development (TD), based at our headquarters in Foster City, CA. The group is responsible for CMC analytical activities related to the development of Gilead’s small molecule drug substances and drug products.
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Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
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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.
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The ideal candidate will have industry experience in a drug discovery and early development setting and have been involved in high throughput screening, lead candidate selection, and IND-enabling studies for biologics.
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The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
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The successful candidate will have deep understanding of liquid and lyophilized formulation development for biologics, protein degradation pathways, biophysical characterization studies, drug product process development, tech transfer, process characterization, risk assessment and implementation of control strategies.
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Interested in learning about machine learning, biochemistry, and the drug development process. Our team has created the industry's most advanced molecular AI platform called GEMS (Genesis Exploration of Molecular Space), to accelerate and optimize small molecule drug discovery and to enable the discovery of novel first-in-class and best-in-class small molecule drugs for challenging and/or undruggable targets.
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This position will support drug development in diverse therapeutic areas such as inflammation, fibrosis, oncology, and virology. The successful candidate will provide scientific and technical overview for tissue-based methods that span sample processing, assay development, whole slide scanning, image QC, analysis, and data reporting.
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Clinical Bioinformatics & Exploratory Analytics, as a part of the Clinical Data Science organization, supports drug development and other business use cases across Gilead by providing data analytical, engineering, and visualization solutions to enable scientific and other business exploration and decision-making, including statistical analysis, genomic data processing and analysis, general machine learning and deep learning, and other technical infrastructure.
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drug development jobs Company: Genoskin in San Carlos, CA
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