Job Description for

R5 Flow Cytometry Principle Scientist

Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectroscopy and Genomics, the Molecular Biomarkers and Diagnostics (MBD) is responsible for clinical biomarker assay development, fit-for-purpose validation, sample analysis and for coordinating the overall strategy and technical efforts in the development and regulatory approval of companion diagnostics at select diagnostic partners.  As part of MBD, the incumbent will play a critical role in the development, validation and implementation of clinical flow cytometry assays.

Responsibility

• Responsible for clinical flow cytometry biomarker assay development and fit-for-purpose analytical validation
• Perform and oversee in-house clinical sample analysis and assay outsourcing to qualified specialty labs
• Provide clinical sample collection and shipping instruction, trouble-shooting, data delivery in line with biomarker plan and timeline
• Ensure documentation of validations and sample analysis is sufficient to support regulatory submissions
• Evaluate & interpret scientific and analytical data.  Drive strategic integration of data into knowledge across programs
• Build and manage relationships with key internal stakeholders and leaders of cross-functional areas
• Serve as departmental representative to assigned Discovery teams, Early Clinical Development teams and Biomarker teams
• Collaborate with internal and external partners to support the Companion Diagnostics when needed
• Manage functional external/global collaborations
• Identify and stay apprised of state-of-art methodologies and relevant research. Provide biomarker assay expertise on academic/industry alliances
   

Education Minimum Requirement:  PhD in a relevant scientific discipline (e.g., Biology, Immunology or Pharmacology), or MD with relevant laboratory and research experience

Required Experience and Skills

• At least 6 years drug development experience in the pharmaceutical industry or research institute with at least 3 years of hand-on experience in clinical flow cytometry assay development, validation and implementation to clinical studies.
• Broad knowledge of translational medicine, biomarker research and technology
• Demonstrated successful leadership in a project or matrix environment, preferably in the pharmaceutical industry
• Strong record of scientific achievement (publications, patents, etc).
• Strong interpersonal, verbal/written communication skills
• Highly flexible with a goal-oriented working style
• Ability to work collaboratively and influence others in a matrix setting
• Demonstrated talent development and managerial skills

       Desired Experience and Skills -  

• Experience with regulated clinical bio-analytical lab
• Experience in managing clinical biomarker assay outsourcing
• Experience in the development of Companion Diagnostics

Please apply online at http://www.merck.com/careers/

Job position ID: RES001416