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Scientist - III (Senior)
Ref No.: 18-15213
Location: KENILWORTH, New Jersey
Translational Biomarkers – Mass Spec contractor. Position Description : Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectroscopy and Genomics, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of clinical development at Client Research Laboratories. Candidate should have a strong interest in Translational Sciences. The individual will have the following responsibilities: • Develop, validate and run clinical biomarker assays using Quantitative QQQ Mass Spectrometry. Provide support for all therapeutic areas and all phases of clinical development at Client. • Assist in the transition of biomarker assays from Basic Research to Clinical by providing technical guidance on fit-for-purpose assay validation. • Interface with scientists and physicians in early and late stage clinical development to execute on biomarker strategies in clinical trials. • Writing memos, final reports and publications summarizing data, and writing/updating lab SOPs. Serve as a subject matter expert in tissue-based assay development and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical trials

Quals--
Position Qualifications: Education Minimum Requirement: • BS, BA, MS or PhD in a life sciences discipline (Biochemistry, Immunology, Molecular Pathology, Cell Biology, etc.) or Chemistry Required Experience and Skills**: • A minimum of 10 (for BS or BA), 5 (for MS) or 0 (for PhD) years of pharmaceutical industry experience • A minimum of 5 years of direct experience in quantitative QQQ Mass Spectrometry assay development and implementation. • Strong interpersonal, verbal and written communication skills • Be able to work independently; strong leadership skills • Ability to execute within a matrixed organization Preferred Experience and Skills: • Broad knowledge of drug development process and translational medicine • Hand-on experience in clinical development/operation or managing the implementation of biomarker assays in support of drug development • Experience with Regulated Clinical bioanalysis