Senior Scientist, Bioanalyticals

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 scientific position builds on past experience, skills and personal attributes of an accomplished bioanalytical scientist. The position involves applying analytical skills to assist in the development and implementation of profit-generating biomarker and biotherapeutic assays. The position also involves the application of validated methods to routine sample analysis. The position is responsible for providing guidance and direction to lower-level LCMS Biologics Scientists and managing communications activities with clients throughout project life to advise of status and to maintain excellent customer relationships.

RESPONSIBILITIES 

• Work under the direction of a Scientific Director or other higher-level scientific personnel to develop, validate and apply new bioanalytical approaches pertaining specifically to LC/MS biomarker and biotherapeutic assays.
• Uphold all safety standards, discipline guidelines and regulatory compliance requirements.
• Maintain accurate documentation during study lifetime and archive material promptly following completion.
• Develop methods including sample preparation, chromatography and mass spectrometry approaches for the detection and quantitation of analytes.
• Conduct all aspects of sample preparation in accordance with position and works with automated extraction instrumentation.
• Make and records observations, performs calculations, and collects and prepares data for evaluation.
• Document all project work according to Quintiles and GLP processes and procedures.
• Perform pipette maintenance and calibration verification.
• Assists with trouble-shooting laboratory instrumentation and other maintenance as required.
• Use LIMS system to schedule samples, set up and edit work lists and manage bioanalytical data.
• Review run binders and notebooks and other project-related documentation.
• Maintain method development documentation in accordance with departmental procedures.
• Build specialized knowledge in chromatographic and mass spectrometric techniques.
• Establish Q² Solutions BioServices as a preferred outsource provider of LCMS Biologics services.
• Communicate with clients regarding progress on scientific and operational objectives.
• Prepare and presents project data and supporting information.
• Contributes to and reviews technical reports.
• Work with team members to manage assigned projects to establish priorities, set schedules, and monitor progress to ensure that projects are progressing satisfactorily.
• Instruct Wet Lab personnel, and other scientific employees as needed, in the proper sample preparation and method development routines.
• Provide guidance and direction to lower-level LCMS Biologics Scientists.
• Manage communications activities with clients throughout project life to advise of status and to maintain excellent customer relationships.
• Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelors Degree in Chemistry or related field
• 2 - 3 years of prior relevant experience.
• Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
• 3 years’ progressively responsible related experience. Equivalent combination of education, training and experience in GLP laboratory environment.

REQUIRED KNOWLEDGE,SKILLS,AND ABILITIES

• Understanding of chromatography and mass spectrometry instrumentation. Ability to maintain clear and efficient method development documentation. Ability to follow verbally communicated or draft procedures.
• Highly experienced in 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 establish and maintain effective working relationships with coworkers, managers and clients.
• Understanding of chromatography and mass spectrometry instrumentation. Ability to maintain clear and efficient method development documentation. Ability to follow verbally communicated or draft procedures.
• Highly experienced in 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 establish and maintain effective working relationships with coworkers, managers and clients.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.