Assoc Resrch Invstgtr, Immunoassay

PURPOSEThe Assistant Research Investigator, Bioanalysis is the senior level scientific position and acts as an authoritative resource regarding the proper procedures and techniques required for scientific and project related matters. Demonstrate a high level of responsibility for the conduct of projects and play an active role mentoring and guiding junior members of the scientific team. Act as the primary point of contact for Quintiles’ external customers, providing exceptional customer service while ensuring that all work meets Quintiles’ scientific standards, continually seeking out better ways to plan and execute projects. Provide a strong leadership presence throughout the organization driving quality science and process improvements.RESPONSIBILITIES Can act as the designee of the Director of Bioanalysis Provide oversight and conduct of a project throughout its life at Quintiles, including method development, method validation, and sample analysis. Provide scientific leadership through all stages of assays including method development, validation and sample analysis Maintain a strong leadership presence throughout the organization by driving scientific quality, process improvement and automation initiatives Maintain all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business. Work with the customer to resolve sample discrepancies. Monitor the progress of all assigned projects and alert management if work falls behind schedule.  Provide regular project status updates to management. Participate in weekly scheduling and revenue update meetings and provide updates on project progress. Prepare validation and sample analysis plans. Review data (run binders, data tables, etc) for regulatory compliance and scientific quality. Address issues from QC and QA review for run binders. Conduct thorough investigations of all failed runs. Lead method troubleshooting investigations. Assemble group of pertinent technical resources and write up investigation report. Prepare corrective and preventative action plans (CaPas) for assigned projects Provide leadership for Technical Writing and QA to ensure projects are completed on schedule. Review validation and bioanalytical reports for completeness. Host customer visits and lead scientific and business discussions. Visit customer sites to discuss ongoing projects and future business possibilities Work with business development staff to prepare quotes for assigned customers. Work towards designing and implementing process improvement initiatives. Approve validation experimental designs. Prepare data for external presentations. Ensure projects are archived in accordance with Quintiles SOPREQUIRED KNOWLEDGE, SKILLS AND ABILITIES Have a broad bioanalytical knowledge base  Ability to achieve results through collaborative efforts with others. Understanding of liquid chromatography and combination with mass spectrometry.  Experienced in sample extraction and routine laboratory procedures. Understanding of method development and validation of assays Ability to interact with external and internal clients, and work to objectives/timelines  Excellent attention to detail and communication skills Ability to provide verbally communicated or draft procedures Ability to establish and maintain effective working relationships with coworkers, managers and clients.JOB DESCRIPTIONPage 2MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor’s Degree in a scientific field with 7 years’ related experience; or equivalent combination of education, training and experience in GLP laboratory environment.PHYSICAL REQUIREMENTS Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time. Some travel required.

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