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Development, optimization, qualification, transfer, validation, and routine execution of analytical methods for proteins, mAbs, drug conjugates using techniques pertinent to LC (SEC, RP, IEX), LCMS, ELISA, CE-SDS, icIEF, and other wet chemistry techniques.
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Prospect biotech and pharmaceutical companies seeking CGT process development and manufacturing partnerships that fit the ElevateBio BaseCamp strategic goals and objectives. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
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Leverage platforms including our proprietary Mercy Halo assay, ELISA, flow cytometry and western blot to support early development activities including biomarker characterization and reagent screening / optimization.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Prior management of contract research organizations (CROs) for clinical biomarker assay development and qualification. Prior experience implementing precision medicine approaches in clinical trials including companion diagnostic (CDx) development experience in liquid-based and tumor tissue-based approaches.
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Collaborate with Supplier Quality team in their communication with material suppliers, related to the development and validation of detailed material specifications for new materials, and the resolution of any quality issues.
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Advanced degree (BS, MS or PhD) in Chemical/Biochemical Engineering, Biochemistry, Immunology, or related degree with experience (8+ for BS, 5+ for MS, 2+ for PhD) in process development and manufacturing sciences in cell therapy, biotechnology, or pharmaceutical industry.
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Serve as point of contact for Development Coordinators and Alumni Relations staff to field basic questions on Prospect Research policies, processes, and procedures. As a key part of Brandeis Prospect Development, the Senior Prospect Research Analyst will actively contribute to the qualification and identification of major donor prospects with the goal of expanding the major donor pool for the organization and assist in implementing a comprehensive Prospect Development program.
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Implementing, monitoring, and participating in the development of site environmental, health and safety programs (Contractor Safety, Ergonomics, Laboratory and Chemical Safety, Hazardous Waste, Wastewater, laboratory inspections, etc.
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We are seeking an experienced, high caliber Senior Electromechanical/Mechatronics Engineer to collaborate with teams in designing and developing complex electro-mechanical medical devices and test equipment to support critical aspects of our product development pipeline.
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Experience in immunoassay product development strongly desired, including reagent development and optimization, assay protocol optimization, migration of manual assays to automated instrumentation, specifications development, statistical methods, verification and validation protocol writing and execution, conformance with design control regulations.
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Work with the various departments on campus, both within and outside Student Affairs to provide educational opportunities around issues of religious diversity, spirituality, and ethics to further the development of students.
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The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates.
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The position is eligible to participate in FM Global’s comprehensive Total Rewards program that includes an incentive plan, generous health and well-being programs, a 401(k) and pension plan, career development opportunities, tuition reimbursement, flexible work, time off allowances and much more.
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This position requires an engineer ready to support multiple projects from ideation to initial proof-of-concept, and even transition to development and commercialization. Training and career development, with onboarding programs for new employees and tuition assistance.
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development job Title: eng Company: Amd in Concord, MA
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