Job Description: Position Description: Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectrometry and Genomics, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of clinical development at Merck Research Laboratories. Candidate should have a strong interest in Translational Sciences. The individual will have the following responsibilities: •Develop and validate immunoassays (ELISA, MSD etc) within TMB for all therapeutic areas and all phases of clinical development. •Assist in lab instrument validation. •Assist in the transition of biomarker assays from Basic Research to Clinical by providing technical guidance on fit-for-purpose assay validation. •Interface with biomarker leads and operation leads in early and late stage clinical development to execute on biomarker strategies in clinical trials. •Writing memos, assay validation reports, clinical sample analysis reports and publications summarizing data, and writing/updating lab SOPs. •Serve as a subject matter expert in immunoassay development and validation, collaborating with project teams, biomarkers leaders, clinical operation and regulatory affairs on the implementation of these assays in clinical trials. Responsibilities: Position Description: Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectrometry and Genomics, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of clinical development at Merck Research Laboratories. Candidate should have a strong interest in Translational Sciences. The individual will have the following responsibilities: •Develop and validate immunoassays (ELISA, MSD etc) within TMB for all therapeutic areas and all phases of clinical development. •Assist in lab instrument validation. •Assist in the transition of biomarker assays from Basic Research to Clinical by providing technical guidance on fit-for-purpose assay validation. •Interface with biomarker leads and operation leads in early and late stage clinical development to execute on biomarker strategies in clinical trials. •Writing memos, assay validation reports, clinical sample analysis reports and publications summarizing data, and writing/updating lab SOPs. •Serve as a subject matter expert in immunoassay development and validation, collaborating with project teams, biomarkers leaders, clinical operation and regulatory affairs on the implementation of these assays in clinical trials. Qualifications: Education Minimum Requirement: •BS in a life sciences discipline (Biochemistry etc.) or Chemistry •MS or PhD preferred. Required Experience and Skills: •A minimum of 7-8 years (BS), 5-6 years (MS) or 3 years (PhD) of pharmaceutical industry experience •A minimum of 5 years of direct experience in immunoassay development •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 bio-analysis Personality: •Flexible •Collaborative •Team Player Software skills: MS office suite(Excel, word, outlook, power-point) Note: Note: Onsite lab based role. Positions available: 1. Possibility of extension. •The key words are: immunoassay or immunochemistry assay (must have), clinical biomarker or biomarker (nice to have). Must haves: •Cell Culture, •Cell sorting, •Flow cytometry, •Invivo experiments, •Immunoassays((ELISA, MSD etc) •Strong Biomarker assays. Innova Solutions
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