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Collaborate with a team of scientists and associates to implement analytical methods and provide analytical support for in-house and contract labs for AAV-based gene therapy products. Perform assay qualification/validation and analytical tech transfer appropriate for the stages of clinical development.
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You will author, review and approve comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD), and lead cross-functional teams to develop business processes and guidelines for coordinated early and late stage analytical development activities in support of biologics commercialization, including post-market life cycle management.
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Associate Scientist, Analytical Development LC/MS. MS in analytical science, chemistry, biochemistry, or related field with 4+ years of industry experience in biopharmaceutical and/or vaccine development.
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Experience with one or more of the following analytical techniques: liquid chromatography (SEC, IEC), capillary electrophoresis (CGE, CE-SDS), capillary isoelectric focusing (cIEF) In Analytical Sciences in Gaithersburg, MD you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Experience working within CMC and tech transfer (e.g. analytical development and/or QC) for cell therapy products. Senior Research Associate, Analytical Development-Flow Cytometry. Experience working within CMC and tech transfer (e.g. analytical development and/or QC) for cell therapy products.
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10+ years of experience in the pharmaceutical industry in the analytics for biologics (analytical development, product characterization or Quality Control of recombinant proteins, monoclonal antibodies, fusion proteins, conjugates and/or vaccines drug candidates.
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Leidos is seeking an Analytical Tradecraft Reviewer to support a client’s requirements in a challenging, dynamic setting located in the Washington Metropolitan Area. The candidate should have extensive knowledge of the Intelligence Community Directive (ICD) 203, Analytic Standards.
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Experience working within CMC and tech transfer (e.g. analytical development and/or QC) for cell therapy products is strongly preferred. We are seeking a self-motivated, detail-oriented Senior Research Associate to join the Analytical Development (AD) team to support process development, stability, and characterization of autologous cell therapy products.
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Considerable expertise relevant to QC analytical methods used for cell therapy. Conduct analytical tests following QC Lab protocols to assess raw materials, components, and products throughout manufacturing stages.
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Collaborating with leaders of the MSAT analytical hubs to review existing process and analytical development and production data; supporting designs and conducting experiments; interprets results; recommends changes of product prioritization based on the portfolio needs.
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We are currently searching for a Chemist to provide services and deliverables through performance of support services for the Chemistry and Synthesis Center (CSC) of the National Heart, Lung, and Blood Institute’s (NHLBI) Division of Intramural Research (DIR.
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