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Partners with CMC, Clinical Development, Clinical Operations and Pharmacology to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance. Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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Pearson VUE ( is the global leader in computer-based testing for information technology, academic, government and professional testing programs around the world. Pearson VUE provides a full suite of services from test development to data management and delivers exams through the world’s most comprehensive and secure network of test centers in more than 180 countries, where we validate the skills and knowledge of millions of individuals every year.
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Working in close collaboration with other Analytical Development team members, the Scientist I/II will develop and qualify advanced biophysical and analytical methods for AAV vectors to measure key quality attributes for AAV therapeutic materials, to support process development, product characterizations, and QC release testing.
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DNA characterization and quality control testing using techniques such as gel electrophoresis, RNaseA testing, nanodrop, PCR, and preparation of samples for sequencing analysis (Sanger and NGS.
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This involves the development of a control system architecture, selecting the components to be used, detailing schematic diagrams and system documentation, programming controllers (PLC, DCS, RTU), programming the process visualization (HMI/SCADA), developing databases for archiving/displaying historical system data and implementing/commissioning the control system at the client’s facility.
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As an viral vector process SME, support other functions including strategy for testing of raw materials, pre-clinical development, reference standards and assay validations, etc. A minimum of 10+ yrs hands on experience in Process Development of cell therapy and/or gene therapy products.
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Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
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Deep expertise and industry experience in cell therapy process development principals including DOE and experience with current technologies in PSC process development and manufacturing, particularly scalable stem cell culture systems such as bioreactors.
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Desired Qualifications: B.S or M.S. Degree in Civil Engineering Licensed Professional Engineer (PE), or (EIT) 3+ years of demonstrated engineering design of Land Development Projects Utility Design Site Grading Storm Water Management Systems Zoning Research Permitting Research Proficiency with AutoCAD, Civil 3D software Salary and Benefits: Comprehensive Salary Package.
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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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Manage day-to-day analytical development and testing activities at CDMOs and contract test labs to ensure that projects remain on track. Develop a method development platform to address unique challenges in testing methods for heterobifunctional small molecule drug candidates for Target Protein Degradation (TPD.
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Understands, conducts, and documents appropriately Dialysis/Apheresis machine safety tests/alarm tests, equipment calibration, dialysate testing, machine safety tests, functional testing, and internal and external disinfection on all water & dialysis machines, and complies with the documentation/notification standards per FMS policies.
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Alloy’s Translational Research team supports our drug discovery partners with in vitro and in vivo testing of therapeutic drug candidates across multiple modalities. You will be responsible for running validated assay systems for the testing of therapeutic biologics, including antibodies and cell therapies.
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Global Discovery and Development Sciences (GDDS) Boston, part of the US R&D hub, is building a new siRNA Nonclinical Development department with cross-functional scientific expertise, including toxicology, safety pharmacology, PKPD, ADME, outsourcing management, and non-clinical project management.
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glp testing development jobs Company: Ascend Advanced Therapies in Burlington, MA
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