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Scientist - III (Senior) - PA/NJ Only

Kenilworth, NJ 07033

Posted: 05/04/2023 Employment Type: Contract Job Category: Scientific Job Number: 562309 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 35-47.49/hr **salary will be commensurate with experience 

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.

Candidate should have a strong interest in Translational Sciences.

The individual will have the following responsibilities:
  • Develop and validate immunoassays 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: • BS,MS or PhD in a life sciences discipline (Biochemistry etc.) or Chemistry • A minimum of 3 years (BS), 1 year (MS) or 0 year (PhD) of pharmaceutical industry experience • A minimum of 3 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 Must haves: Cell Culture, Cell sorting, Invivo experiments, Immunoassays, Biomarker assays. 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: Onsite lab based role. The key words are: immunoassay or immunochemistry assay (must have), clinical biomarker or biomarker (nice to have).
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