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Associate II, Global External Manufacturing, Small Molecule Drug Substance (DS) works to support uninterrupted supply of Gilead's clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations.
$99,790 - $129,140 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This role is primarily focused on CMO(s) for AAV/gene therapy drug substance manufacturing. Manage and oversee cGMP operations at Adverum’s drug substance CMO to ensure manufacture of Adverum products on-time and meeting quality, compliance, and applicable regulatory requirements.
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Senior Associate, Global External Manufacturing, Small Molecule Drug Substance (DS) works to support uninterrupted supply of Gilead's clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations.
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Strong working knowledge of full CMC spectrum, including drug substance and drug product manufacturing, stability requirements, analytical and formulation development and GMP manufacturing considerations in general.
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This role will also provide support when needed for drug substance manufacturing, supply chain, and analytical development activities. Review documents associated with drug product development and manufacturing, including but not limited to change controls, manufacturing batch records, protocols, investigations/deviations, and reports, and organize and archive documents in Veeva Quality Docs System.
$123,100 - $144,900 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Associate Director, Drug Substance Manufacturing is responsible for supporting Sagimet’s drug substance activities, from early development through Phase 3 clinical supply to NDA registration activities and preparation for commercial manufacturing.
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Manage development activities for cGMP drug substance manufacturing of small molecule drugs at CMOs. The Director, Chemical Development & Drug Substance Manufacturing is self-motivated and demonstrates initiative in responsibilities and always strives to do the job better.
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Experience in small molecule drug substance and solid oral dose production and development, packaging/labeling/serialization, third-party logistics, and supporting continuous clinical trial medicine supplies.
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Working knowledge of small molecule drug development and commercialization, including raw material and starting material sourcing, API/drug substance manufacturing, process development, process engineering, and process characterization.
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This position will be reporting to the VP of CMC and will support the drug development and manufacturing activities for phase 3 and commercialization at CDMOs and CTLs for Biologic programs.
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And drug substance pilot plant. Well versed in FDA and ICH guidelines relating to registration, quality and compliance concerning drug substance. for all of Gilead’s biologics entities during pre-pivotal phases of development (pre-clinical, phase I/II.
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This Senior Manager position and their direct reports will be collaborating with the following groups: small molecule drug substance (development and manufacturing), drug product (development and manufacturing), analytical, regulatory, quality (QA and QC), supply chain, packaging/device and labeling, and the Global Development and Program Strategy teams.
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