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Biologics cell culture: upstream (Fed-Batch, Perfusion, XD, etc.) Minimum of 15 years professional working experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience with at least 5 years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections.
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Prepare technology portfolio with drug delivery solutions that can address delivery of new modalities, peptide therapeutics, biologics, and small molecules including ability for line extension and life cycle management.
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The successful candidate will have a strong background and proven track record in all activities encompassing upstream and downstream processes for the manufacturing of biologics, in support of IND enabling submissions.
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Experience in biologics and/or cell and gene therapy manufacturing equipment. 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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Contributes US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications. As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics.
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A proven track record of establishing and/or using cutting edge protein engineering technologies (either internal or external) to progress an innovative biologics pipeline is key. You will work in close collaboration with scientific leaders across the global Research organization and beyond (e.g., Biologics Drug Product/CMC teams) to deliver on our Biologics pipeline.
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Our offerings will span across our technology platforms, Process and Analytical Development, Drug Substance and Drug Product offerings from pre-clinical to late phase / commercial supply across five modalities (Cell/Gene/Nucleic Acids/Biologics/Vaccines.
$160,000 - $235,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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We combine this and other high-throughput protein engineering approaches with computational design to create antibody-like drugs and other biologics. 2+ years hands-on molecular biology wet lab experience, including PCR and cloning (design, bacterial transformation, culture, plating, and plasmid purification, next-generation DNA sequencing library preparation.
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Advanced Degree in science, law, health policy, regulatory affairs or engineering and 8+ years of demonstrated experience in device, pharmaceutical/biologics regulatory, or scientific discipline including at least 3 years of demonstrated experience specifically in regulatory affairs work.
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You possess scientific understanding, particularly in biologics drug discovery, vital for steering product strategy in a science-driven marketplace. Through a community of partners, we democratize access to pre-competitive tools, technologies, services, and company creation capabilities that are foundational for discovering and developing therapeutic biologics.
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As a Product Designer for Modified Biologics, you will partner with our talented team delivering solutions for scientists using breakthrough techniques in DNA, RNA, protein and antibody design and analysis to drive science forward.
$159,885 - $216,315 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Biogen is searching for a biophysicist to fill a Senior Scientist position within the Analytical Development (AD) - Biologics/Advanced Therapies & Medicinal Products (ATMP) department in Cambridge, MA. This key technical leadership role will lead the biophysical and higher-order-structure characterization for biologics and advanced therapies including monoclonal antibodies, antibody conjugates, bispecific antibodies, therapeutic proteins, and AAV-based gene therapy.
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Familiarity with drug development processes for biologics. Leads the analysis of complex business problems and manages business requirements within area of responsibilities (Vaccine Manufacturing and Supply functions.
$108,500 - $170,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience nominating development candidates, ideally antibodies, protein therapeutics, or other types of biologics. As a member of our team, you will be responsible for designing and executing experiments to understand activity, mechanism of action, and therapeutic potential of early-stage biologics.
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Either as a scientist (academia or industry), engineer, or IT project manager - preferably in Large Molecule Biologics, Cell Therapy, Gene Therapy, or a related field. either as a scientist (academia or industry), engineer, or IT project manager - preferably in Large Molecule Biologics, Cell Therapy, Gene Therapy, or a related field.
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biologics job in Boston, MA
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