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The Vice Preside of CMC Radiopharmaceutical Process Development will provide oversights to cell line development, antibody process development and scale up, conjugation and radio drug substance and drug product development and GMP manufacturing.
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Progressing formulation development activities, including stability studies for thermal, freeze/thaw, and agitation as well as container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.
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Residential programs run 24/7 and Individual and group therapy, family therapy, individualized case management, treatment planning, drug and alcohol counseling, medication support services, and crisis intervention.
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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.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions (such as Drug Product Development, Drug Substance Development, Analytical/QC, and Quality teams.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Director, Global External Manufacturing Bulk Drug Substance (BDS) ensures 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.
$205,700 - $266,200 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Manager, Global External Manufacturing, Small Molecule Drug Substance (DS) works to ensure 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.
$133,280 - $172,480 a yearExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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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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 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 6 days ago - UpvoteDownvoteShare Job
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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
$221,170 - $286,220Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 5 days ago
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