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Overview Performs any basic to complex Analytical assay(s) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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ElevateBio is looking for a Cell Therapy Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events.
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PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
$101,383 - $124,846 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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A minimum of 10 years in similar cGMP environments with broad knowledge of Quality Control procedures, bioanalytical, chemistry, microbiology assays for sterility, endotoxin, TOC, and stability programs required for biologic therapies.
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The Principal Research Scientist II will ensure phase-appropriate assay validation compliant with internal policies and cGMP requirements. The Principal Research Scientist II will ensure departmental compliance with cGMP requirements, will lead method validation activities and any relevant investigations/audits associated with QC activities of the department.
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Quality control sample management experience in the pharmaceutical industry supporting cGMP areas preferred. The Sample Management Consultant position will interact with Quality Assurance (QA), Product Quality Lead (PQL), Supply Chain, Logistics, Translational Sciences/Process Development, and Analytical Development Teams.
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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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Document control, archive, archival, archivist, doc control, qa, quality assurance, quality associate, quality specialist, quality assurance specialist, gmp, cgmp, gxp, mastercontrol, veeva vault, edms, document management system, pharma, biopharma, medical device, biotech, biotechnology, fda, quality systems, qms, eqms, clinical manufacturing, commercial manufacturing, novel pharmaceutical, novel drug, novel therapeutic.
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How to apply your experience in bioprocess & cell culture to the production of next-generation seafood utilizing cGMP practices. We were founded in 2016 by Aryé Elfenbein, a cardiologist and molecular biologist, and Justin Kolbeck (CEO), a former US diplomat who served in Pakistan and Afghanistan, in an effort to solve one of the world's biggest problems: how to feed a growing population without stripping the earth of its natural resources and biodiversity.
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Maintain a current knowledge of applicable phase appropriate FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices. In addition to conducting activities that ensure the biologics manufacture and facility is compliant with applicable regulations, policies, procedures and expectations of phase appropriate current Good Manufacturing Practices (cGMP.
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With game studios in Stockholm, Malmö, London, Barcelona and Berlin, and offices in Dublin, San Francisco, New York, Los Angeles, and Malta, we have a 20- year history of delivering some of the world’s most iconic games in the mobile gaming industry and are on a mission to level- up the little moments for our more than 200 million active monthly users.
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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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Supervise QC analyst(s) Responsible for QC data/records to ensure content adheres to established cGMP quality standards. Familiarity with cGMP Quality Control Testing, Qualification, and validation of analytical test methods compliant to Good Laboratory and Documentation Practices.
$150,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Capacitación y cumplimiento de las Buenas Prácticas de Manufactura actuales (cGMP) y otras políticas de la empresa. Tues. Nov. 2 - OSIFT Mingle, Portland Old Spaghetti Factory - 715 S Bancroft St.
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Subject Matter Expert in cGMP upstream manufacturing; especially with Mammalian Cell Culture, Roller Bottles, Rocker Bioreactors, Fed batch and Profusion Bioreactors, Cell Harvest Clarification, Viral Inactivation, Buffer and Media preparation, and equipment preparation.
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