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Research Investigator / Expert, Translational Sciences Wilmington United States,
Posted on : 04 July 2017
This position will be integrated in a highly collaborative and dynamic environment and will be considered the laboratory expert responsible for implementing pharmacodynamic (PD) and correlative bio-marker assays in support of clinical trials.
Summary of the Essential Functions of the Job
- Working within the Transnational Sciences group, the individual will be the in-house expert primarily responsible for developing, performing, and validating assays assessing target inhibition and measuring exploratory biomarkers to support clinical trials.
- Utilize cell-based assays, immunoassays (ELISA, ELLA, and/or MSD), multiplexed assays and flow cytometry to assess PD markers and exploratory biomarkers.
- Requires a full knowledge of industry practices in order to analyze data, evaluate experimental results and plan actions based on the results.
- Ability to explore and implement new technology.
- Responsible for preparing and reviewing SOPs, validation/qualification reports, bioanalytical reports and summary sections for clinical documents such as IBs, DSURs and CSRs.
- Capable of working on multiple projects simultaneously, organizing his/her workload to meet deadlines and working both independently and collaboratively to achieve goals.
- The candidate must be able to coordinate with others within the group and outside the group to track projects, samples and deliverables.
- BS/MS/Ph.D. or equivalent experience in the Life Sciences or related discipline plus 5-8 years of relevant experience.
- Experience with cell culture, cell-based assays, immunoassays and flow cytometry required.
- Experience working with human blood and tissues, using BSL1 and BSL2 laboratory procedures.
- An understanding of the drug development process and familiarity with clinical labs is a plus.
- Skilled in Microsoft Office with skills in analytic software such as GraphPad Prism Vortex, etc. preferred.
- The candidate must be an excellent team player and highly motivated to work in a fast-paced environment.
- Strong interpersonal, written and verbal communication skills.
- Ability to work independently with limited supervision, but in a team setting.
- Strong organizational and documentation skills.
- Ability to work occasional weekends or non-routine hours.
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