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This individual would be responsible for analytical cell-based assay development, qualification, and operational support for Preclinical, Phase 1 and Phase 3 of clinical products for Solid Biosciences.
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This is a hands-on role, where the successful candidate will have strong experience with analytical assay development for nucleic acids (RNA) and LNP formulations. The scientist will be a vital part of the Technical Development team, playing a key role in shaping FL85’s analytical development capabilities.
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We are recruiting a Scientist II/Sr. Scientist I with experience in phase-appropriate analytical method development, optimization, and qualification of physicochemical assays for lot release, stability, and characterization of cell and gene therapy products to support Beam's in vivo programs using lipid nanoparticle (LNP) delivery.
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Innovative mindset to join our Analytical Development group in Woburn, MA. Strong preference will be given to a candidate with proven experience in developing biophysical and analytical chemistry assays like SEC-MALS, HPLCs, CE-SDS, iCIEF as it relates to biologics and gene therapy products.
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Technical lead of analytical method development for nucleic acids, lipids, & lipid nanoparticles as part of development of FL85 platform, product, process, and formulations. FL85 is seeking a Director of Analytical Development to join our team to lead development of assays focused on CMC development of products based on FL85's novel technology platform.
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Position Summary Editas is seeking a Senior Development Associate to join our Analytical Development group. Requirements Required Qualifications: The ideal candidate will possess: B.S. in chemistry, biotechnology, biomedical engineering, or related field with 2+ years of relevant experience (5+ years for Associate Sci I) M.S. in chemistry, biotechnology, biomedical engineering, or related field with 0-2 years of relevant experience (3+ years for Associate Sci I) Experience and/or familiarity with HPLC/UHPLC assay development is required.
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Orbital is seeking an experienced Director of Analytical Development who will be responsible for leading, directing, and implementing a comprehensive analytical strategy in support of programs within vaccine, immunomodulation, and protein therapeutics.
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Familiarity with Good Manufacturing Practices (GMP) and ability to ensure analytical methods meet regulatory requirements for the cell therapy product development. The full-time role will be a key Analytical Development team member, focusing on developing, qualifying, and transferring assays for the release and characterization of gene-edited human pluripotent and hematopoietic stem cells.
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The mRNA Analytical Development Head of Quality Control within mRNA Analytical Sciences Department, Center of Excellence (CoE) will be responsible for management of GxP testing at CROs as well as establishing a QC laboratory in support of Manufacturing for programs from preclinical to clinical phases.
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Scorpion Therapeutics is seeking a highly skilled and motivated Senior Scientist, Analytical Development to join our CMC team. Strong understanding of regulatory requirements (e.g., FDA, ICH) governing analytical development and quality control in drug development.
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A leading biotech company focused on developing novel therapeutic products is looking for a talented Analytical Scientist with a strong background in cell and gene therapies to join their team.
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Reporting to our Senior Scientist, Analytical Development, we are seeking a Senior Research Associate, Analytical Development to join our organization. Collaborate effectively across both research and process development teams for phase-appropriate analytical support at required timelines.
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Experience in analytical development and characterization of particles, antibody-drug conjugate, viral vectors, or other biologics (5+ years) is a key technical leadership role in the Department of Analytical Development (AD) at Aura Biosciences where the candidate will contribute by developing methods and performing product characterization through state-of-the-art biophysical methods and generating data to meet regulatory expectations for the Biological License Application (BLA) of Belzupacap sarotalocan, (Bel-sar, AU-011.
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Reporting to Head of Technical Operations CMC, the Director – Analytical Development is an accomplished technical expert in the diverse techniques, instruments, and methods applied to analytical characterization across API starting materials, through to intermediates, on to drug substance, and finally drug product for small molecule pharmaceutical development programs.
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The position is responsible for analytical development, analytical technology transfer and validation, and overall management of CMC activities related to external QC testing/release and stability of antibody drug conjugates and intermediates.
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Title: analytical development in Cambridge, MA
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