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Ensures that toxicology studies and programs are conducted in accordance with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Senior Scientific Director, Toxicology About the Role:As a Sr. Leader, executes the strategic direction of the Toxicology function.
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Ensure compliance with applicable regulatory requirements, including FDA, USDA, AAALAC, OLAW, DEA, OSHA, and environmental health and safety regulations, as well as industry standards such as Good Laboratory Practices (GLP) and Good Documentation Practices (GDP.
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Develop knowledge of requirements (commercial, Regulatory, cGMP, GDP, GLP, ISO-, etc.) Basic laboratory coordination as needed (order supplies, lab housekeeping, organize and maintain equipment.
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Under supervision, the Research Associate will perform laboratory experiments such as RNAi and CRISPR gene editing in various cell lines and animal models, effect of various drugs on the brain, single cell RNSeq, ATAC-Seq, data generation, and analyses, preparation of reports and presentations.
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Capable of using statistical techniques: sampling theory, probability, reliability, and capability, SPC, GR&R, MSA, DOE, IQ/OQ/PQ and GLP. Capable of using statistical techniques: sampling theory, probability, reliability, and capability, SPC, GR&R, MSA, DOE, IQ/OQ/PQ and GLP.
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Provides strategic and operational direction ensuring that toxicology studies are conducted in line with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Oversee and provide direction in the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.
$366,875 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Familiarity with Good Laboratory Practice (GLP) minimum of a Bachelor's degree from an accredited university in microbiology, molecular biology, or related course work in biological sciences, and at least one (1) year of laboratory bench experience outside of an academic environment, utilizing PCR, aseptic techniques, and biological assays.
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Represent Preclinical development on discovery and development teams and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Safety Pharmacology and Toxicology findings.
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Advises and directs the analysis, interpretation and reporting of Safety Pharmacology and Toxicology data for discovery and development programs. Designs and develops overall Safety Pharmacology and Toxicology development strategies for toxicology programs.
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Oversees and evaluates protocol preparation for toxicology studies and reviews reports. Supports Sr. Leadership with in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management.
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Familiarity with laboratory safety standards and Good Laboratory Practice (GLP). Ensures all data is entered and maintained according to Good Laboratory Practice (GLP) guidelines.
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Certification in laboratory safety or related fields (e.g., biosafety, chemical safety). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted.
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7) Assist with ordering supplies, keeping inventory, and basic laboratory supply management as well as other tasks as required by the supervisor. Familiarity with basic laboratory equipment such as centrifuges, spectrophotometers, balances, pH meters, autoclaves, and electrophoresis equipment.
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Works in collaboration with other Research and Development Team members and with Company leadership to ensure safety pharmacology and toxicology support is provided to ensure provision of requisite data in a timely manner to meet development goals.
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Critically evaluate toxicology results and provides timely strategic advice to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy ·Oversee and provide direction in the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.
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glp job Title: laboratory in San Diego, CA
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