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Performs Cell Culture and Cell-Based assays (BSL2 and BSL2+) 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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Biologist, biology, mammalian cell, cell culture, protein purification, aseptic, cell banking, GMP, cGMP, cell production, upstream, downstream. Experience in aseptic processing techniques and some understanding of regulatory requirements for a cGMP manufacturing facility.
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They have unmatched experience in pioneering the early viral vectors of two FDapproved AAV gene therapy products seeking a Head of Facility Operations to manage cGMP for the facility (drive cGMP and own SOPs around design, control, documentation, investigations, training, e.g. access, calibration schedule , if interested in learning more please apply.
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Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility are required. Provide oversight of the manufacturing process, ensuring technicians follow cGMP practices and utilize proper aseptic techniques.
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The QA Technician is responsible for providing quality support to the manufacturing floor, auditing batch production documentation, dispositioning intermediates and equipment after cleaning, performing in process checks, reviewing and approving incident reports, revise quality documents (e.g. SOP, protocols, methods), and ensuring adherence to cGMP.
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In addition, our team also works on projects with clients to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D. This includes analyzing various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Associate Scientist - QC Manufacturing performs and directs assays 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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What You’ll BringA minimum of 10 years of process engineering design experience in cGMP, FDA, or other regulated manufacturing environments. Subject-matter expertise in cGMP regulations and standards (preferred.
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This position collaborates with the Validation Manager to execute and verify qualification test cases on new cGMP equipment. cGMP/GLP Facilities Equipment Manager (CVPF) In order to support these labs, this position must fully comply with FDA regulated cGMP (current Good Manufacturing Practices) and GLP (Good Laboratory Practices) and well as FACT accreditation guidelines.
$43,919 - $66,183 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Demonstrated work experience in compliance with cGMP and FDA requirements, including Good Documentation Practices (GDP). Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
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Knowledge of and adherence to all PCI, EHS, cGMP, and GCP policies, procedures, rules. These duties include but are not limited to: Installation and drywall repair, Painting, Carpentry, Intermediate plumbing, Intermediate electrical work and installation, HVAC PM's and repairs, Filter changes, Ceiling tile installation and maintenance, assembly of furniture and equipment, Snow and ice removal.
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The Facilities Specialist will troubleshoot, repair and maintain facilities that includes infrastructure, utilities and equipment while ensuring the systems' safety, compliance and cGMP regulatory when applicable.
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Manage cGMP for the facility (drive cGMP and own SOPs around design, control, documentation, investigations, training, e.g. access, calibration schedule, etc.) Project manage cGMP facility shutdowns aligning key stakeholders and ensuring successful return to production.
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Desirable 1+ years’ experience working within cGMP regulated environment including Good Documentation Practices (GDP) 1+ years’ experience with Mammalian Cell Culture Experience working in an aseptic cleanroom with a full aseptic gowning is a plus At Adaptimmune we embrace diversity and equality of opportunity.
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Participates in the development and/or revision of Standard Operating Procedures (SOPs) and follows it when performing any work in cGMP areas or when it is applicable. Familiarity with Building Management Systems (BMS) and Computerized Maintenance Management Systems (CMMS.
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cgmp job in Audubon, NJ
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