Associate Research Investigator

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Overview
This LCMS Biologics Scientist builds on past experience, skills and personal attributes of an accomplished bioanalytical scientist, and requires the ability to act independently with little or no guidance. The position involves applying analytical skills to assist in the development and implementation of profit-generating biomarker assays. An advanced understanding of nano-flow chromatography and modern quadrupole or time-of-flight mass spectrometry instrumentation, development/validation of methodology, biological sample preparation, interpreting of data, interacting with clients, and working to objectives/timelines are integral to this position.

Essential Functions
• Work under the general guidance  of a Scientific Director to develop and validate new bioanalytical approaches pertaining specifically to biomarker and biotherapeutic assays for disease mechanism investigations and support of drug development studies. Work with key clients to implement this service in accordance with their expectations. Develop methods including sample preparation, chromatography and mass spectrometry approaches for the detection and quantitation of identified biomarker compounds. Validate associated methodologies to a fit-for-purpose extent. Coordinate application of validated methods to sample analysis. Manage bioanalytical data in Watson LIMS. Communicate with clients regarding progress on scientific and operational objectives. Work with management to set work plans, goals and metrics to build this service. Prepare and presents project data and supporting information. Contributes to and reviews technical reports. Attends scientific meetings and client visits to promote Quintiles’s LCMS Biologics business. Train less experienced scientific co-workers, when necessary, to support growth of LCMS Biologics service. Validate methods to regulatory (GLP) standards. Oversee the application of the validated methods to routine sample analysis. Oversee daily management of intra- and inter-organizational relationships to ensure timely completion of projects in accordance with customer specification. Provide frequent communication of project status with clients. Prepare and make external presentations of Quintiles’s LCMS Biologics capabilities to clients and prospective clients. Apply analytical skills to assist in the development and implementation of profit-generating assays. Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.

Qualifications
• Bachelor's Degree in Chemistry/Bioanalytical Chemistry or a related field Req
• 5 years’ progressively responsible related experience. Equivalent combination of education, training and experience in GLP laboratory environment.
• Understanding of chromatography and mass spectrometry instrumentation. Understanding of all routine laboratory procedures. Understanding of development/validation of methodology. Understanding of wet-laboratory sample extraction. Ability to interact with clients, and work to objectives/timelines. Excellent attention to detail and communication skills. Ability to maintain clear and efficient method development documentation. Ability to provide verbally communicated or draft procedures. Advanced understanding of nano-flow chromatography and modern quadrupole or time-of-flight mass spectrometry instrumentation, development/validation of methodology, biological sample preparation, interpreting of data. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Understanding of chromatography and mass spectrometry instrumentation. Understanding of all routine laboratory procedures. Understanding of development/validation of methodology. Understanding of wet-laboratory sample extraction. Ability to interact with clients, and work to objectives/timelines. Excellent attention to detail and communication skills. Ability to maintain clear and efficient method development documentation. Ability to provide verbally communicated or draft procedures. Advanced understanding of nano-flow chromatography and modern quadrupole or time-of-flight mass spectrometry instrumentation, development/validation of methodology, biological sample preparation, interpreting of data. Ability to establish and maintain effective working relationships with coworkers, managers and clients.