Senior Immunoassay Bioanalytical Project Manager

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. 

Job Overview
The BioServices Project Manager is the primary point of contact for our external customers.  The focus of the BioServices Project Manager is to provide exceptional customer service while ensuring that all work meets IQVIA scientific standards.

RESPONSIBILITIES 

• Provide oversight and conduct of a project throughout its life at Quintiles, including method development, method validation, and sample analysis.
• Serve as Principal Investigator for GLP studies.
• Work closely with Technical Writing and QA to ensure projects are completed on schedule.
• Review validation and bioanalytical reports for completeness.
• 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.
• Submit accurate weekly assessment of resource requirements  for scheduling purposes.
• 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.
• Provide project trackers for client communications and lead regular teleconferences to discuss project progress.
• Coordinate customer visits. Visit customers.
• Work with business development staff to prepare quotes for assigned customers.
• Approve validation experimental designs.
• Prepare data for external presentations.
• Ensure projects are archived in accordance with Quintiles SOP.
• Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's Degree scientific field
• 5 years’ related experience. Equivalent combination of education, training and experience in GLP laboratory environment.

REQUIRED KNOWLEDGE,SKILLS,AND ABILITIES

• Ability to achieve results through collaborative efforts with others.
• Understanding of liquid chromatography and combination with mass spectrometry or In vitro and Immunoassay techniques.
• 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.
• Ability to achieve results through collaborative efforts with others.
• Understanding of liquid chromatography and combination with mass spectrometry or In vitro and Immunoassay techniques.
• 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.

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.