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Possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13. Possess clinical supplies experience/knowledge in forecasting, demand / supply planning, IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export, and reverse logistics.
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Awareness of comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, ICH/GDP, GCP, 21 CFR Part 11 and EU CTR Annex VI, etc. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
$205,700 - $266,200 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Job Description Key Responsibilities Manager, Global External Manufacturing, Sterile Drug Product 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 yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Work in compliance to AV Procedures and cGMP guidelines. As an Incoming Quality Assurance (IQA) Inspector, you will be responsible for the visual and dimensional inspection of incoming components/materials (i.e., injection molded plastics, thermoformed plastics, metals, machined components, extrusions, and metal tubing), information for use (IFUs), packaging, and labeling materials.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Expertise in Quality Systems and cGMP standards applicable to method validation for clinical and commercial products and AO/QC laboratory operations. May assist with cGMP compliance audits at contract partners and may interface with regulatory agencies during inspections.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Support the change management process, ensuring compliance with cGMP. Perform master batch record review and executed batch record review. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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Good understanding of basic ISO13485 / FDA’s QSR/cGMP requirements. Good understanding of basic ISO13485 / FDA’s QSR/cGMP requirements. We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease.
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As a quality functional site lead at CTLs, supports quality initiatives and responsible for providing quality metrics, trend reviews, and risk assessments. Experience in a Pharma / Biotech GMP environment and a Bachelor's degree in chemistry, biology, or related scientific field.
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3+ years in a ISO/cGMP production environment. This position reports to the Chips Manufacturing Manager. Participate on project teams for new products as well as investigations and CAPA. Title: Senior Manufacturing Technician.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Responsibilities include managing QC samples, shipping, and testing logistics, reference standard inventories, and data entry from CTLs/CMOs into Gilead's LIMS. The role will contribute to QC procedures across Gilead's biologics manufacturing network, ensuring global cGMP compliance.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Knowledge of cGMP Quality Systems including change control, discrepancy management, CAPA, lot release and validation. cGMP Cell Culture or Purification experience required. 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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The Sr. Manager will be responsible for leading all facets of Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP.
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The role will contribute to refining QC procedures across Gileads biologics manufacturing network, ensuring compliance with global cGMP and Gileads Quality Management System. The role will contribute to QC procedures across Gileads biologics manufacturing network, ensuring global cGMP compliance.
ExpandApply NowActive JobUpdated 3 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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Experience/knowledge in forecasting, demand / supply planning , IRT systems, responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with.
ExpandApply NowActive JobUpdated 11 days ago
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