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Follows/Ensures GLP (good laboratory practices) and GMP (good manufacturing practices) compliance. Basic knowledge in Data management, Google Docs, LIMS, and Continuous Improvement. FBI Cyber Crime resource page.
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Design, manage and conduct nonclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including pharmacology, toxicology, and biodistribution studies. What you'll do:Conduct nonclinical development activities (pharmacology and toxicology) for IND-enablement of gene therapy products.
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Demonstrates a thorough knowledge of Good Clinical Practice GCP, Good Pharmacovigilance Practices GVP, Good Laboratory Practice GLP, Good Documentation Practice GDP and ICH E6 R2 compliance requirements.
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In addition, our pre-clinical vaccine program, VAX-A1, is moving into a period of high intensity focus in preparation for GLP and GMP work. Participate in process development activities for commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and ongoing commercial manufacturing.
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Knowledge & Other Requirements Thorough knowledge of standards, systems, policies and procedures that enable QMS operations and compliance within the biopharma industry, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC.
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7 years of progressive experience in operational leadership in R&D and GMP/GLP laboratory, biotechnology or pharmaceutical environment. Understand laboratory supply streams, waste streams, and have experience working in an R&D and GMP and GLP laboratory environment.
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Providing legal support and guidance on data integrity and compliance issues impacting CMC, product quality, GCP, GLP and GMP; Gilead is seeking a development and regulatory counsel to join its Global Development & PDM Legal Business Partner team.
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Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
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Participate in laboratory clean-up and ensure adherence to cGMP, GLP, and safety policies and procedures. Perform high purity water testing with guidance or support. Participate in laboratory clean-up and ensure adherence to cGMP, GLP, and safety policies and procedures.
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Key FunctionsThe primary focus of the position is the management/support of a diverse portfolio of drug programs in discovery, development (regulated GLP toxicology studies), and post marketing products.
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Knowledge of Current Good Manufacturing Practice (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), GAMP5, 21 CFR part 11 and ICH. Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform.
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The Senior Scientist I, Pilot Lab Operations will be responsible for leading the pilot lab operations including GLP biologics drug substance manufacturing, process transfer, pilot lab facility and equipment readiness, manufacturing operation scheduling, planning, preparation and execution.
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It is necessary to possess working knowledge of GxP(GMP, GLP, GCP) regulations as they pertain to the shipment, receipt, and storage of regulated materials. Biotechnology company is hiring a Sr. Supply Chain Analyst to oversee material inventory and storage and manage global material shipments company's service provider and partner ecosystem.
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R&D Quality and Medical Governance (Q&MG) is seeking an Associate Director, Functional Quality Business Partner (GLP/ GCLP) to join our high-performing team to support Research and Development functions at Gilead.
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Develop and communicate corporate compliance policies and standards for GMP operations and partner with peers in clinical operations to support the development and maintenance of similar documents for GVP, GLP, and GCP operations.
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glp job in Menlo Park, CA
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