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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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Experience with LIMS or ELN Foundational knowledge of GDP, GLP A high level of flexibility to support various other activities; the ability to learn new techniques outside of existing field of expertise.
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The QAU will support the comparable GMP production activities related to GLP toxicology lot production and technical transfer activities as it relates to clinical batch release testing conducted at GTP to support the clinical CMO. The QAU will also provide Quality Assurance support to the research-based portion of the GTP, in terms of SOP management, training, document management and archiving, and audit support.
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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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Overseeing internal technical milestones, including research vector production, process/technology development, and GLP/GMP vector production. Overseeing internal technical milestones, including research vector production, process/technology development, and GLP/GMP vector production.
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Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, GCP, GLP, GMP, QSR, etc.) Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, GCP, GLP, GMP, QSR, etc.
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Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, Google Cloud Platform, GLP, GMP, QSR, etc.) Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, Google Cloud Platform, GLP, GMP, QSR, etc.
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Inspect testing facilities to ensure framework is in place for studies to be conducted in compliance with GLP requirements. Advise staff on GLP policies. Inspect testing facilities to ensure framework is in place for studies to be conducted in compliance with GLP requirements.
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Strong Scientific Background: Candidate must have prior experience in cell and gene therapy and transfection, with proficiency in both suspension and adherent methods for cell culture. Aligning stakeholder expectations and facilitating timely decision-making to ensure project milestones are achieved efficiently and effectively within the dynamic landscape of cell and gene therapy development.
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Supervisory experienced in CLIA certified or other GLP laboratory preferred. Experience: Minimum 3 years of experience in a CLIA certified or other GLP laboratory plus 2 years of general laboratory experience or equivalent combination of education and related experience required.
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Products or Services Sold - Analytical Services for Cell and Gene Therapy, GLP Bioanalysis, Manufacturing of Biological Products. Familiarity with GLP and possibly GMP regulations. Products or Services Sold - Analytical Services for Cell and Gene Therapy, GLP Bioanalysis, Manufacturing of Biological Products.
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QQUALIFICATIONS: Bachelor's degree in Biology or related science 1-3 years of experience in a GLP/GCP/GMP setting, or equivalent, with >1 year of direct experience in Quality role Excellent verbal and written communication skills and interpersonal skills Detail oriented, and Excellent organizational record keeping Flexibility to work with schedule changes Knowledge of manufacturing biologics product and cell and gene therapy principles and technologies preferred.
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