Sr. Scientist / Principal Scientist

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Sr Scientist/Principal Scientist with strong research skills in Cell-Mediated Immunology (CMI) and analytical development to lead a group in Translation Medicine focused on the pipeline of biological candidates (infectious diseases, vaccines, oncology, RIA). The ideal candidate would be a skilled scientist who has direct experience in the application of CMI bioanalytic development with expertise in cell-based assays for understanding immunological responses to pathogens, foreign antigens and vaccines, for support of epidemiologic studies and biomarker discovery.
Candidate must have experience working in a matrixed organization supporting the implementation of analytical methods that meet the needs of cross-functional teams (i.e. Product Development Team). Critical to this position is the ability to support the transition of methods from development into fit-for-use assays (qualified and/or validated) that can be used to make program decisions. The scope of responsibility includes managing analytical scientists to move a method into a GLP testing environment by leading the scientific and compliance aspects required for full implementation and testing. Implementation includes internal and external technology transfer, data management (quality and compliance), assay performance monitoring, generation of critical reagents, etc.
Responsibilities:
- Communicates key scientific, technical and operational issues to members of Translational Sciences, Clinical Operations and Clinical subteams.
- Contribute to the overall strategic planning and prioritization of biomarker studies supporting pipeline candidate drug development;
- Coordinate and lead staff to deliver key technologies, systems and processes to support assay development, validation and clinical testing including laboratory information management systems (LIMS), data management (bioinformatics, proteomics, data analysis, curve fitting, etc.) and compliance systems;
- Interface and provide scientific leadership as Subject Matter Expert with multiple internal stakeholders and teams within R
- Coordinate technology/methods transfer to external collaborators and CROs;
- Establish collaborations with internal customers (cross departmental/therapeutic areas);
- Establish external collaborations (academic, industry) that support new NAT technology and pipeline development;
- Develop SOPs, data transfer specification forms, Corrective Actions and Preventative Actions;
- Manage a team of scientists supporting clinical development by working with assay automation, Clinical Sample and Data Management (CS
- Effectively present results of work in internal and external meetings.