Support execution of internal and external registration studies for the INTERCEPT Blood System for Red Blood Cells.
Assist in planning and conduct of internal and external registration studies. Prepare and manipulate various blood products, including RBCs. Perform and appropriately document notebook studies. Perform functional assays. Make detailed observations, analyze data, and interpret results. Prepare and present experimental results in appropriate forums. Prepare technical reports, summaries, protocols, and quantitative analyses. May present at scientific conferences and contribute to scientific publications. May mentor or provide guidance to other personnel. Maintains high level of professional expertise through familiarity with scientific literature. Work cross functionally with Clinical, Regulatory, Quality and Biostatistics departments. Perform other related duties as required. Qualifications/Requirements/Skills:
Bachelor’s degree in a scientific discipline with minimum 5 years of experience, or Master’s degree in a scientific discipline with a minimum 2 years of experience. Experience with performing broad spectrum of assays Experience working with human blood products desirable. Experience working in a GLP or other regulated environment desirable. Proficient in writing reports, regulatory submissions, and publications. Strong attention to detail and accuracy. Strong mathematics skills. Familiarity with word processing, spreadsheet, scientific and graphics applications. Sharp analytical skills; problem-solving, trouble-shooting, innovative. Team oriented. Ability to work independently. Good communication skills (verbal, written, interpersonal, listening). Flexible; ability to adapt to changing priorities. Time management (schedules, timelines, task prioritization). Able to travel domestically All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.