Research Scientist/Study Director

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    "requisitionDescription": "<div><div><div><div><div><div><link href=\"https://static.workforcenow.adp.com/mas/mdf-components/24.23.14/styles/froala_editor.pkgd.min.css\" rel=\"stylesheet\" type=\"text/css\"></div><p id=\"isPasted\"><strong>Role Summary</strong></p><p>The <strong>Research Scientist </strong>(RS) will be engaged in serving as the single point of study control and overall planning and conduct of the study in accordance with applicable regulatory guidelines and contemporary scientific practice. &nbsp;Additionally, the RS will ensure that all Good Laboratory Practices (GLP) are met, and that the outcome of the study is valid and reliable. <strong>This role requires experience with LBA method development, GLP-compliant method validation, and GLP-compliant sample analysis, including MSD/ELISA and ADA is a must.</strong> This includes experience with sponsor interaction, protocol development, and data interpretation experience as well. This is an exempt role with no supervisory responsibility.</p><p><strong>Role Responsibilities</strong></p><ul><li>Serve as the Principal Investigator/Study Director/Bioanalytical Monitor for internal and external studies. &nbsp;Has overall responsibility for the technical conduct of the study, interpretation and reporting of results in accordance with regulatory agencies, protocols, amendments, methods, and standard operating procedures.&nbsp;</li><li>Develop protocols and ensures that the protocol, and any amendments, are approved and followed.&nbsp;</li><li>Ensure all experimental data, deviations, and unanticipated events are accurately recorded and any corrective actions needed are documented.&nbsp;</li><li>Establish and maintain relationships with industry and scientific thought leaders through effective communication and scientific expertise.&nbsp;</li><li>Ensure that all raw data, documentation, protocols, specimens, and final reports are archived at the conclusion of the study&nbsp;</li><li>Develop NBS&rsquo; scientific knowledge and expertise in gene and cell therapy.&nbsp;</li><li>Drive efficiencies through automation/new technologies in sample preparation, analysis and reporting.&nbsp;</li><li>Write and review reports and SOPs.&nbsp;</li><li>Communicate with management and Sponsors regarding project issues, changes, and requirements.&nbsp;</li><li>Mentor and guide junior scientist and technicians.&nbsp;</li><li>Other duties as assigned.</li></ul><p><strong>Role Requirements</strong></p><ul><li>Bachelor&rsquo;s degree or equivalent in a scientific related discipline required. &nbsp;A Master&rsquo;s degree or Ph.D. is preferred.&nbsp;</li><li>Minimum of 10 years of related scientific experience. &nbsp;A combination of education and experience may be accepted&nbsp;</li><li>Strong background in immunology and plate-based assay development with experience in bioanalytical method validation.</li><li>Experience with a wide variety of ligand binding assays for biomarker, protein quantification, and anti-drug antibody analysis.</li><li>Experience with regulated studies along with a solid understanding of study design and protocols&nbsp;</li><li>Knowledge of GLPs and other federal regulations relating to the company&nbsp;</li><li>Solid understanding of laboratory operations and data collection&nbsp;</li><li>Self-starter, able to prioritize work, and work efficiently with minimal supervision&nbsp;</li><li>Excellent analytical and problem-solving skills&nbsp;</li><li>Excellent verbal and written communication skills; ability to design, interpret, and present scientific data in a team environment is preferred &nbsp;</li><li>Proficiency with Microsoft Office core applications and the ability to learn and use additional applications.</li></ul><p><strong>Behavioral Expectations</strong></p><ul><li>Collaboration&nbsp;</li><li>Flexibility&nbsp;</li><li>Leadership&nbsp;</li></ul><p><strong>Special Requirements</strong></p><ul><li>The person filling this position will spend approximately 60% in an office setting and 40% in the laboratory. There will be exposure to animal pathogens and chemicals. There will be handling of, and/or exposure to, animal tissue and zoonotic organisms.</li><li>Ability to don and wear personal protective gear, including N95 masks and respirators</li><li>Physical requirements: &nbsp;Ability to lift and carry up to 50lbs. &nbsp;</li></ul><div><div class=\"fr-view\"><p><br></p></div></div></div></div></div></div></div>\n",
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