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Education: BA or MS in Cell biology Immunology, Molecular biology, virology, biochemistry, microbiology, or other related science. Thorough general knowledge of bioassay test methods (e.g. Elisa, Flow cytometry, qPCR, cell culture.
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Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies.
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Highly proficient in Molecular Biology principles and technologies including PCR and basic sequence analysis required. Assist in developing and implementing data analyses, applications, and workflows to expand our Next Generation Sequencing (NGS) services and data processing capabilities.
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7 or more years of experience within pharmacovigilance, clinical pharmacology, preclinical research, toxicology and/or biomarker validation (especially in industry) required. 7 or more years of experience within pharmacovigilance, clinical pharmacology, preclinical research, toxicology and/or biomarker validation (especially in industry) required.
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Study outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead e.g. review Tables/Listings/Graphs before database lock and quality check of data; Works with BD&O to ensure SAP update.
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A Bachelors Degree or better in Biology, Planning, Environmental Studies, Environmental and Earth Science, or a related field is required. Bachelors of Biology (required) Experience with state permitting requirements (including waterbody, floodplain, and SWPPP permits) in OH, WV, VA, KY, TN, or PA. (required.
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Required Skills: Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or related areas. Conduct weekly meetings with Contract Test Labs (CTL) to provide testing forecast, generate sample submission, provide shipping details to CMO, tract testing status and be point of contact for any test status question in collaboration with ERMs. Work cross functionally to provide single point of contact for CTL sample management to internal teams and external manufacturing partners, as needed.
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Insmed is seeking a part-time scientist for the pre-clinical in vivo pharmacology group with prior experience in the maintenance and breeding of highly sensitive genetically modified mouse strains.
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Minimum qualifications include a bachelor's degree in environmental science, natural resources, biology, ecology, planning, or related field, and 5 to 15 years of post-degree environmental permitting experience in New Jersey.
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Knowledge/Skills/Education: Required Bachelors degree in biochemistry, cell biology, microbiology, chemistry, engineering or related areas. 3 years industry experience in Laboratory Operations or related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies.
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Requires a bachelor’s degree in science, preferably in Biochemistry, Chemistry, Molecular and Cellular Biology, or related discipline. Additionally, the assistant QC Chemist will be responsible for continuous improvement of the lab management processes from the New Brunswick and Summit West methods development laboratories.
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Bachelor's degree required; scientific field (chemistry, biology) or professional medical required (MD, PharmD, RN, etc. The successful candidate will provide quality expertise to manage and improve processes across Aquestive's development program, ensuring compliance with Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Preclinical stage and GMP for clinical manufacturing oversight.
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The incumbent will collaborate with other departments such as molecular biology, upstream process development, and process development analytics. Client Biologics Development has a Cell Line Development and 'Omics organization that includes Molecular Biology, Cell Line Development, and Multi-Omics.
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BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field. At least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required.
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Requirements Bachelor's degree in Biology, Microbiology, or other laboratory-based life science; or equivalent combination of education and experience. This is a multidisciplinary role & this individual will further interface across many parts of the company to develop novel products used in the cell therapy and gene therapy world.
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pharmacology biology jobs in Basking Ridge, NJ
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