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Expert in the use and interpretation of modern analytical techniques, e.g. HPLC, MS, GC, NMR (1D and 2-D), KF, DSC, TGA, XRD, optical microscopy, particle attribute characterization, Reporting to the Vice President, CMC, the Director will manage and lead the Analytical development function ensuring the development and implementation of phase appropriate methods that meet international regulatory requirements for drug substance and drug product safety.
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Manage developing, validating, and standardizing complex GC, GC/MS, HPLC, LC/MS, ICP/MS analytical methods for isolation, detection, identification, and quantification of both drug substances and drug products of small molecules or/and large molecules.
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Experience with RNA or Oligonucleotide analytical chemistry and biophysical techniques is helpful, preferably in biopharmaceutically relevant systems. BS in analytical chemistry, biochemistry, or relevant discipline with 8+ years of relevant experience, or M.S. with 6+ years relevant industry experience, or PhD with 1+ years industry experience.
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Perform a variety of analytical methods ranging from basic to complex using HPLC, GC, AA, FTIR, UV and wet chemistry methods. Previous analytical chemistry including HPLC, GC and AA experience preferred.
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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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Principal Associate Scientist for Analytical Development - Contract - Cambridge, MA. Perform testing or data analysis of siRNA utilizing analytical techniques such as pH, Osmolality, and UV Assay.
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PhD in Analytical Chemistry, Biochemistry with emphasis in mass spectrometry. Experience in peptide method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
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Hold role of technical leader for analytical development projects, and provide strategic and scientific input across bioprocess development projects. who will own and drive execution of our analytical development roadmap with the aim of establishing capabilities to test Induced-Pluripotent-Stem-Cell (iPSC) clones at a high level of throughput and quality.
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You will be reporting to the Senior Director of Analytical Development and provide technology development, strategic leadership, scientific and technical expertise in protein biologics method development, optimization, and qualification/validation.
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Hands-on experience and knowledge of a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, and mass spectroscopy. The Scientist, Analytical Development & Quality Control is responsible for analytical development, feasibility, method qualification, routine, and stability testing of antibody drug conjugates and intermediates.
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A common data continuum ecosystem across diverse teams, including Research & Biomarkers (R&B), Process Development & Industrialization (PD&I), Analytical Sciences ( Lead the alignment of scientific and data practices across different teams and sites within Analytical Science.
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The Research Associate will perform analytical chemistry and biophysical methods for the testing of AAV gene therapy products, to support process development and product characterizations. BS or MS in Biophysics, Biochemistry, Analytical Chemistry or a related discipline with relevant lab experience.
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Be an interface between Analytical Development and QC GMP to support assay transfer, qualification, and validation. You will contribute to assay development and sample testing of in-process samples, drug substance, and drug product using analytical tools.
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S/he will work with a Beam’s Analytical Development team to enable the rapid advancement of cell and gene therapy candidates from clinical development through commercialization. We are seeking a motivated Scientist/Sr. Scientist to join our Analytical Research and Development team and perform method development and qualification for lot release and characterization of cell and gene therapy products and critical materials.
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Assess and implement new analytical platforms, such as DLS, SEC-MALS, etc., to determine AAV capsid identity, quality, and quantity. Investigate and evaluate cutting edge biophysical and analytical instrumentation.
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Title: analytical Company: Zeichner Risk Analytics Zra in Burlington, MA
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