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Associate Project Manager, LCMS Bioanalytical - (1804936) in Ithaca, NY at IQVIA™

Date Posted: 2/28/2018

Job Snapshot

Job Description

Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.


The Associate LCMS Bioanalytical Manager the primary point of contact for our external customers. This focus of this role is to provide exceptional customer service while ensuring that all work meets Q2 Solutions scientific standards.
  • Provide oversight and conduct of a project throughout its life at Q2 Solutions, 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.
  • 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.
  • 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.
  • Organize method troubleshooting investigations. Assemble group of pertinent technical resources and write up investigation report..
  • 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 Q2 Solutions SOPs.
  • Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.

Job Requirements

  • Ability to achieve results through collaborative efforts with others.
  • Understanding of LCMS bioanalysis (i.e., LEAP, Nexera, Dionix, Acquity) and MS System (SCIEX, Vantage, Q Exactive).
  • Understanding of statistics and its application to data analysis
  • Understanding of method development, validation, and sample analysis of PK and Immunogenicity 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.

  • Bachelor's Degree in Biology, Biochemistry, or related scientific field required, Master’s Degree preferred. Minimum of 3 years' related experience in GLP laboratory environment.
  • Previous CRO experience highly desired.
  • Previous scientific bench experienced desired, but not required.
  • Previous experience in LCMS Bioanalysis highly desired.  
EEO Minorities/Females/Protected Veterans/Disabled

Job ID: 1804936