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Description: Job Summary:Performs pre-analytical, analytical and post-analytical phase testing of all complexities as defined by Clinical Laboratory Improvement Act/Amendment (CLIA) to include specialized tests and analysis in one or more areas of clinical laboratory such as Hematology, Microbiology, Clinical Chemistry, Urinalysis, Immunohematology, Serology, Parasitology and chemical and morphological examinations to obtain data for use in diagnosis and recording laboratory test results.
$63.52 - $68.72 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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For Microbiology, Virology, Cytology or Genomics Labs only: PHM California Certified Public Health Microbiologist; or CGMBS Clinical Genetic Molecular Biology Scientist. Conducts statistical analysis of tests using clinical laboratory techniques in chemistry, biochemistry, immunology, microbiology or related laboratory specialties.
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Manages upstream product development marketing activities such as defining product requirements, KOL feedback analysis, surgeon design team management, pre-clinical and clinical evaluation/validation, budgeting, forecasting, and inventory planning.
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3 or more years industry experience in Laboratory Operations or related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies. Work closely with Global Product Quality, External Manufacturing, and Supply Chain to understand forecasts and deadlines to ensure timely CoA/CoT (Certificate of Analysis/Certificate of Testing) generation for Cell Therapy vector products.
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Through close collaboration with in vivo scientists and the Pfizer clinical biomarker labs develop novel biomarker hypothesis and implement novel technologies. Candidates should possess a sophisticated understanding of modern cancer biology, cancer genetics and immuno-oncology, with a documented focus on translational research and clinical biospecimen analysis in phase 1 clinical trials.
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The budget specialist is responsible for reviewing the Medicare coverage analysis, protocol, sponsor proposed budget and informed consent (if available) and fully accounting for all clinical costs and investigator and study team effort required to carry out the study, as well as costs for ancillary services.
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Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Quality Inspection Specialist.
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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.
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Implements new bioinformatic and computational methods for large-scale biological/clinical data analysis as required by specific projects. Understands the biological and clinical concepts driving the research to facilitate productive discussions of data analysis.
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The markets we serve include food manufactures and labs, clinical and healthcare, pharma, and biotech. Intermediate computer skills: proficient in data analysis using Microsoft Excel and familiarity with SAP ERP system is a plus.
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As a summer intern in our group, you will have project opportunities to partner with laboratory and data scientists in our Research Labs to apply advanced computational methods (such as natural language processing, image analysis, machine learning, and data engineering) across our Company's Discovery and Pre-clinical Development enterprise.
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Related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies. related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies.
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The CICL's primary throughput is quantitative imaging analysis data which is sent directly to the sponsor or CRO.There are thirty plus staff consisting of physician leadership, statisticians, cardiac imaging specialists and project management staff serving 30-40 ongoing clinical trials at any given point.
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Assists the QC Supervisor, QC Lead, and other QC team members by escalating concerns and answering technical questions from laboratory staff and others in Exact Sciences labs, as appropriate. Prepares QC, proficiency testing, patient, and other specimen types for analysis, analyzer-to-analyzer, and lot-to-lot testing.
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Participates in validation of clinical testing and development of new clinical assays to be run in the Clinical Genomics and Advanced Technology Lab. Maintains quality control/quality assurance as designated by the genomics Lead. Analyzes, reports, and troubleshoots data generated from clinical genomics technologies and assays such as but not limited to NGS, PCR, FISH, karyotyping, RFLP analysis.
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