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Leads CMC regulatory activities for investigational, late development and/or early commercial GSK products. Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
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This position requires a Ph. D. (or an equivalent foreign degree) in Biotechnology, Cell Biology, or a closely related specialty scientific field and 1 year of experience as a Data Scientist or similar occupation involving Translational Medicine experience developing and implementing clinical biomarker strategies within early or late stage clinical development programs in oncology.
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This position reports to the Principal Scientist, Translational Biomarkers, and the position’s activities would span all clinical and late-stage preclinical programs. The successful candidate will work closely with cross-functional teams, including Translational & Clinical Development, Nonclinical, Research, and Bioanalytical, to drive biomarker strategy and ensure the integration of biomarker data into the drug development process.
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Familiarity with proteomics, genomics, or other ‘omics data is advantageous, including an ability to converse and collaborate with in-house bioinformaticians. This includes interpreting complex datasets from clinical trials and biomarker studies to support drug development strategies.
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Lead and/or contribute to clinical asset biomarker strategy within early and late-stage clinical development antibody drug conjugate (ADC) programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient selection.
$217,350 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Experience managing Biomarker and/or CDx aspects of early and late stage clinical programs including sample management, working with CROs and Diagnostic partners. Drive the implementation of the clinical diagnostic strategy for therapeutic programs in early and late stage oncology clinical development.
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The Associate Scientist, Bioanalytical Development & Operations will be a member of the growing Translational Science team to support ongoing clinical trials of Viridian therapeutic antibody programs, as well as upcoming late discovery programs.
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Founded in 1948, Brandeis University is named for the late Louis Dembitz Brandeis, the distinguished associate justice of the United States Supreme Court, and reflects the ideals of academic excellence and social justice he personified.
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Technical and GMP expert that will be responsible for supporting analytical method lifecycle activities at external AD/QC laboratories for late-phase antibody-drug conjugate (ADC) development. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.
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With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Act as the company liaison on CMC Regulatory matters and support related meetings, including preparation of briefing books, training, and preparing the technical team.
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The goal of this position is to advance innovation in our manufacturing capabilities by developing robust, scalable, automated, and data-driven cell culture processes for Client’s diverse early and late-stage biologics pipeline.
$60 an hourExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Critically evaluate relevant scientific, technological, and regulatory literature to advance the proposed platform and its impact in our early and late-stage biologics pipeline. Relevant knowledge, coursework and/or hands-on experience in mammalian cell culture process development (e.g., cell biology and biochemistry, cell culture engineering, recombinant protein production, bioreactor engineering, protein product characterization, sterility and aseptic techniques, technology transfer, etc.
ExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Lead CMC regulatory execution for specific programs at all stages of development. Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC.
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As a part of the global project team, the successful applicant will contribute to the development of clinical protocols, provide scientific and technical support for regulatory communications and filings, as well as define the strategy for and assays supporting serology, mucosal/ cell mediated immunogenicity, efficacy-supporting diagnostics, and next generation sequencing endpoints for a late stage program.
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late job Title: room in Natick, MA
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