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Sr.) Manager, QC Analytical Development 2022031 Location: United States (Remote) Science/ Focus: Protein Therapeutics Therapeutic Area: Hematology Job Overview: As the Senior Analytical Scientist Consultant, you will oversee various analytical projects and ensure that assays comply with all regulations and guidelines, supporting clinical studies, product licensure, and commercialization.
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Reporting to a lead within the Process Sciences team, CARGO Therapeutics is seeking a highly motivated and versatile individual to join us as a Senior Scientist in Analytical Development within the Process Sciences organization.
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We are establishing commercial processes that require a solid practical foundation in standard bioprocess unit operations (e.g. bioreactors, chromatography, UF/DF, normal flow filtration, mixing and novel harvesting systems.
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The Principal Scientist role in the Analytical Development and Operations (ADO) organization reports to the Senior Director of Analytical Development (AD). Principal Scientist I, Small Molecule Analytical Development, Analytical Development and Operations.
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Extensive expertise in U/HPLC, CE, SDS-PAGE, mass spectrometry, and other analytical technologies as applied to protein analytical method development, trouble shooting and validation for GMP release and stability testing.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Playing a critical role as the subject matter expert (SME) and project lead of Analytical Development within CMC function, the position will be responsible for analytical method development/validation/transfer and managing release testing, reference standard qualification and stability programs in support of Revolution Medicines pipeline compound development and clinical programs.
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Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Analytical Development, Process R&D, Project Management and Regulatory to timely achieve project goals.
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In this position, you will work closely with the Process Development, Quality Control, Quality Assurance, Translational Medicine, Biometrics, and Regulatory team members and will contribute to novel assay development for product understanding of CARGO Therapeutics’ pipeline candidates, fit‑for‑purpose method qualification, SOP/technical report authoring/review, life cycle management of assays, data analysis, and execution of routine analytical testing.
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Expertise in the conception, formulation, optimization, automation, processing, characterization and manufacture of a unique silicone polymer composition of a specialty medical device including analytical chemical testing including gas and liquid chromatography, gel permeation chromatography (SEC), UV/Vis, FTIR, viscosity testing.
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This role is in the Analytical Development & Operations (ADO) group within Technical Development (TD), based at our headquarters in Foster City, CA. The group is responsible for CMC analytical activities related to the development of Gilead’s small molecule drug substances and drug products.
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Expertise in small molecule analytical development through hands-on experience in design, execution and data analysis of laboratory techniques, including modern chromatography operating systems and through leading analytical development projects Broad understanding of both scientific and regulatory requirements in the areas of responsibility and overall pharmaceutical R&D, as well as manufacturing and qualityDemonstrated ability in identifying and crafting technical and innovations strategies.
$221,170 - $286,220Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Routine analysis of internal stability samples and reporting of data using HPLC, spectroscopy, immunoassay and physical analytical methodologies. Further, the candidate will develop analytical methods, perform analytical data review, and support assay transfer activities with the QC team and CMP partner groups.
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The candidate will work independently to develop analytical methods, perform analytical data review, authorship of protocols and reports, coordination and oversight during assay transfer with the Vaxcyte QC team and external CMO partner groups.
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Experience with analytical methods such as XRD, SEM, TEM, XPS, BET, IR, TPD\TPR, HPLC, GC, MS, etc. Maintain analytical equipment and assist in method development. Experience with analytical methods such as XRD, SEM, TEM, XPS, BET, IR, TPD\TPR, HPLC, GC, MS, etc.
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San Mateo County Health is seeking an inquisitive and highly analytical individual for the position of Administrative Services Manager I-Behavioral Health and Recovery Services to oversee the Division's administrative and billing functions.
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