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The Manager / Senior Manager, GMP Quality Control will work closely with cross-functional teams to assess, monitor, and enhance quality systems, ensuring that all GMP data adhere to relevant regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Experience in performing phase-appropriate assay qualification/validation in a GLP or GMP environment. You will have demonstrated experience, leadership, and independence with QC functions associated with the GMP production and testing of cell/gene therapy products or biologics in both clinical and/or commercial settings.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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DDITIONAL SKILLS: Laboratory, Maintenance, Method Validation, GMP, QA, Radioactive, SOPs, Validation Protocols, Analytical Assays, Bioassay, Biochemistry, Cellular, Cellular Biology, Immunology, Operations, Good Documentation Practices.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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This position entails testing for GMP release and stability along with support for the validation and qualification of ELISA and Cell Based Assays. ELISA, cell-based bioassay, analytical test, bioassay, GMP, Trackwise, SAP, 5S, large molecule bioassay, analytical technique.
$30 - $35 an hourExpandUpdated 4 days ago - UpvoteDownvoteShare Job
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Responsible for the qualification of cleaning manufacturing equipment independently in aseptic filling and GMP areas, including autoclave, Vessel Equipment validation, Sterilization in Place of filling vessels and COP validation in accordance with corporate and departmental procedures.
Full-timeExpandUpdated 11 days ago - UpvoteDownvoteShare Job
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Key Words: Field Service Engineer | HPLC | LCMS | MALDI | Prep LC | SFC | Maintenance | GMP | GLP | Service Schedules | Installation | Validation | Instrumentation | IQOQ | SAP | Troubleshooting.
ExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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SME experience in the following areas is preferred: Sterilization Validation (autoclave and vessel SIP) Cleaning Validation Other job-related skills/Background: Familiarity with Good Manufacturing Practices Must have demonstrated self-direct work habits and strong communication skills.
Full-timeExpandUpdated 22 days ago - UpvoteDownvoteShare Job
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You will be a part of the Analytical Method Development (AMD) and report to the Principal Scientist responsible for development and optimization of analytical methods that will be used for investigative testing, GMP release testing, and stability testing of Aldevron Products (e.g., nucleic acids, lipid nanoparticles.
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ELISA, HPLC, GMP, Stability Testing, Assay Development, method development, characterization, immunotherapy, assay validation, microbiology, environmental monitoring, cell based assay, potency assay, physico-chemical assays.
ExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements. Lead pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, process optimization, and process validation activities related to solid oral dosage and parenteral drug products.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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This includes expertise, as well as coaching and mentorship of frontline Process Control Engineers in the following areas: automation control system configuration, change control and project delivery, deviation investigation, Computer System Validation (CSV) , data mining and analysis, and routine automation computer system support activities.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Solid Dose Process Development Scientist will report to the Facilities and Engineering Manager in support of process development, scale up, and process validation. Author and review GMP documentation related to process development (protocols, Design of Experiments (DOEs), SOPs, Change Controls.
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Actively ensures GMP quality, safety, environmental, and operating cost goals are achieved. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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As a Validation Engineer III, under the direction of the Process Engineering Manager, you will be responsible for assisting Vector and GMP personnel with all aspects of the equipment life cycle, including equipment specification, installation, and validation.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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In collaboration with Senior Automation Engineer and/or Associate Director, Automation, support the installation and validation of a PI data historian for the commercial manufacturing facility. Strong knowledge of GMP quality systems.
ExpandApply NowActive JobUpdated 4 days ago
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