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The group supports non-GMP transient protein lead production across the companies diverse biotherapeutic discovery portfolio to enable the research units and their pre-clinical therapeutic in-vitro and in-vivo needs.
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Implement and lead technology transfer, process validation, and GMP manufacturing in support of Drug Product fill/finish for early and late-stage clinical supply through launch/BLA. They will collaborate with various internal functions including Analytical, Upstream/Downstream Manufacturing, Quality Control, Quality Assurance, Regulatory, and Supply Chain to ensure best practices are implemented and followed at external contract manufacturing and testing labs, and internally at Leap Therapeutics.
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Collaborating with cross-functional teams including upstream marketing, sales, sales support, clinical specialists, market intelligence. Downstream Services Marketing Director - Hospital Patient Monitoring.
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Promote and develop process improvements for clinical sample lifecycle management including specimen collection, tracking and downstream storage and/or destruction. Prepare and review key study start up documents such as clinical study protocols, clinical kit development, lab manuals and consent forms, and to verify that biological samples are collected as specified in the protocol and related plans.
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The individual will execute relevant protocols to purify therapeutic oligonucleotides suitable for downstream in vivo studies. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
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The Manager, Packaging Engineer will provide technical expertise associated with pharmaceutical packaging and serialization programs for Blueprint Medicine's clinical and commercial products, including packaging design and specification, equipment/tooling design, qualification and validation, artwork & labeling, material selection and testing.
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Selling Thermo Fisher's downstream chromatography products (POROS Chromatography and CaptureSelect Affinity resins and columns) into process development and clinical/commercial manufacturing groups within biopharma accounts.
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The Research Production team is responsible for the upstream enzymatic synthesis and downstream manufacturing of drug substance to support pre-clinical trials. Downstream experience with standard chromatography and/or DNA purification kits is a plus.
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Contribute to the scale-down and scale-up of downstream processes for clinical and commercial production. Downstream AKTA Protein Purification & Chromatography experience in GMP environment.
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In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
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Sail Biomedicines is seeking a highly motivated and innovative Associate Director, Drug Substance Process Development to be the subject matter expert and leader of RNA manufacturing processes, including upstream and downstream activities.
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Accountable for all downstream development activities, including life-cycle management, externalization, due-diligence, academic partnerships, and in-licensing, across the entire product life-cycle, from pre-clinical to commercialization.
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Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.
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Ensure accuracy of data entry to prevent compliance and/or downstream process issues. The incumbent assesses the request, conducts all necessary research such as verifying benefit coverage for the patient, and then creates the case (data entry) in Highmark's utilization management system for clinical review.
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You'll collaborate closely with our Process Liquids Solutions Technical Sales Executives (TSEs) to identify and cultivate opportunities for custom cGMP process liquids manufacturing services, aimed at simplifying bioprocess workflows both upstream and downstream.
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downstream clinical jobs in Boston, MA
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