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Experience in the operational Quality Management of (CMO) Contract Manufacturing Organizations producing products on behalf of another pharmaceutical company. The senior manager of GMP Quality will be responsible for interfacing with global contract manufacturing organizations (CMOs) and providing GMP Quality oversight both internally and externally related to the quality management system, deviations, CAPAs, change control, technical transfer activities while ensuring activities are performed according to applicable guidelines and regulations.
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QC, Supplier Quality), you will provide Quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines at GTMF and/or contract manufacturing organizations (CMO.
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Oversight of outsourcing activities such as scale-up and technology transfer to contract manufacturing sites (CMO) partners for clinical trial manufacture externally as well as support clinical trial material manufacture within Vertex.
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Experienced in all phases of biologics, gene therapy, and/or cell therapy drug development. The Director, CMC QA will report to the Executive Director of CMC QA and be responsible for maintaining strategic responsibility over QA Operations, developing and implementing Ultragenyx CMC Quality approach for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality.
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You will have responsibility for Quality Assurance, and support of Quality Control, for external Oncology and Small Molecule manufacturing ( contract manufacturing organizations, or CMO ), and external testing ( contract test labs, or CTL ), inclusive of Drug Products, packaging, and labeling activities, located within the US/North American region.
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This position works closely with key stake holders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO's), and Contract Research Operations (CRO's) to ensure seamless supply of Clinical Trial Material.
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Strategic sourcing and procurement experience with extensive knowledge of category management and complex contract negotiations expertise in direct and indirect procurement. Experience with clinical outsourcing and CMO manufacturing a plus.
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Contributes to the setup of a new CMO (contract manufacturing organization) and extensions to existing manufacturing and supply network for. Experience with IT integration of external partners such as Contract Manufacturing Organization.
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Oversight of contract CMO and CRO vendors. Our client is a clinical-stage biopharma company developing precision oncology medicines using its proprietary proteomics platform to develop drug-specific companion diagnostics.
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ResponsibilitiesEnsures compliance to cGMP, policies and procedures for documentation resulting from manufacturing operations for clinical and commercial small molecule API and DP.Provides quality oversight of CMO operations for API and DP, including the approval of protocols, product specifications, API and DP manufacturing documents and records, method validation protocols and reports, process validation plans and reports, and stability protocols and reports.
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In this role you will report to the Associate Director and will work directly with our Qualified Treatment Centers, Contract Manufacturing Organizations, Distribution partners, logistics providers and bluebird bio cross functional teams.
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The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical Trial Material (CTM), including work performed by Contract Manufacturing Organizations (CMOs.
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Contributes to the setup of a new CMO (contract manufacturing organization) and extensions to existing manufacturing and supply network for Qdenga. Leads the analysis of complex business problems and manages business requirements within area of responsibilities (Vaccine Manufacturing and Supply functions.
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The Director, External Manufacturing, will report to the VP, Commercial Manufacturing & Supply Chain, and is accountable for the business, relationship and operational management of all activities performed within Viridian's Contract Manufacturing Organization (CMO) network (includes biologics Drug Substance and Drug Product manufacturing, device component production, combination device assembly and commercial finished goods production.
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Supports identification and resolution of business/contract issues (bring in legal, CMSC LT, Strategy+Bus Ops, Strategic Sourcing). The candidate will be in a remote role, with travel to CMO sites routinely as a "Person-in-Plant.
$132,800 - $199,200 a yearFull-timeRemoteExpandApply NowActive JobUpdated 8 days ago
cmo contract jobs in Waltham, MA
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