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Minimum of 7 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company.
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Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers.
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Relevant experience in analytical development in a CMC setting, including assay qualification, validation and tech transfer for biologics or cell therapy is a plus. Bachelor's or Master's degree in a biological science discipline required ( e.g. , developmental biology, cell biology, immunology, or related pharmaceutical science.
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Proclinical is seeking an (Associate) Director, US Regulatory Affairs, Advertising & Promotion for a large global pharmaceutical company with locations in Georgia, North Carolina and Massachusetts.
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Recognized expert within process architecture discipline, specific to biologics and pharmaceutical manufacturing. Stays current in global regulations impacting facility attributes for the manufacture of biologics and pharmaceutical drug substance and drug product.
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Strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries.
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Experience in Oncology Sales is preferred and specialty biologics markets highly desirable. Pharmaceutical marketing experience developing marketing programs and materials for healthcare professionals and patients a plus.
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Knowledge of analytical methods commonly used in the quality testing of Pharmaceutical Biologics. Theoretical and practical knowledge of applying and developing separation and mass spectrometric methods for characterizing biologics.
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Strong pharmaceutical project management skills and proven experience in having managed capital projects with emphasis on Biologics, clinical and/or manufacturing and development laboratories in a cGMP environment.
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Responsibilities will include sample management and stability lab set up, writing procedures and reports and supporting lab analysts with initial lab equipment installation, qualification, and validation.
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Execute protocols and perform assay transfer/validation and equipment qualification/verification. Perform complex assay and instrument troubleshooting. Proven record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journal.
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Diverse background relating to pharmaceutical, biologics or gene/cell therapy development, and/or drug/device combo development, including direct working knowledge of Quality Control, Quality Assurance and/or Quality Enterprise systems.
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The Senior Director of CMC Commercial Assets sits within the Pharmaceutical Operations & Technology team (PO&T) and is responsible for the end-to-end strategy of all commercial assets in all therapeutic areas and all modalities.
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This position will be stationed in an office and laboratory environment involving work near moving/mechanical parts; working around various chemicals including biologics, active pharmaceuticals, beta-lactams and radioactive materials; and other conditions reasonably expected due to the nature of the work required.
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Significant knowledge of biologics manufacturing and analytical methodology as well as ICH, cGMP, EMEA and JP guidelines as they pertain to the manufacturing of monoclonal antibody-based therapies required.
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biologics pharmaceutical jobs in Cary, NC
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