Immunoassay Bioanalytical Project Manager / Study Director
Location:
Marietta , Georgia
Posted:
December 20, 2017
Reference:
1720598
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.

Description


The Immunoassay Project Manager / Study Director is the primary point of contact for our external customers. The focus of this role is to provide exceptional customer service while ensuring that all work meets Q2 Solutions scientific standards.



  • Provide oversight on the study throughout its life at Q2 Solutions, including method development, method validation, and sample analysis.
  • Work closely with Method Development, Technical Writing, QC, and QA to ensure studies 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 studies and alert management if work falls behind schedule.
  • Provide regular status updates to management including full service project managers.
  • Participate in weekly scheduling and revenue update meetings and provide updates on study progress. Submit accurate weekly assessment of resource requirements for scheduling purposes.
  • Prepare validation and sample analysis plans.
  • Prepare data including but not limited to setting cut points and creating data tables.
  • Perform an overall review to provide statistical analysis/recommendations based on the data.
  • 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 study progress.
  • Coordinate customer visits and where needed visit customers.
  • Work with business development staff to prepare quotes for assigned customers.
  • Approve validation experimental designs.
  • Prepare data for external presentations.
  • Ensure studies align with all regulatory guidance and Q2 SOPs.
  • Ensure studies are archived in accordance with Q2 Solutions SOP.




  • Ability to achieve results through collaborative efforts with others.
  • Understanding of Ligand binding assays and Immunoassays for large molecule PK and Immunogenicity analysis.
  • Experienced with conducting PK and Immunogenicity assays including cut point setting.
  • 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.


Job Requirements



  • Ability to achieve results through collaborative efforts with others.
  • Understanding of Ligand binding assays and Immunoassays for large molecule PK and Immunogenicity analysis.
  • Experienced with conducting PK and Immunogenicity assays including cut point setting.
  • 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 5 years' related experience in GLP laboratory environment.
  • Previous CRO experience highly desired.
  • Previous scientific bench experienced desired, but not required.
  • Previous experience in Immunoassay / Immunogenicity highly desired.



  • 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.


EEO Minorities/Females/Protected Veterans/Disabled

A little about us:
IQVIA™ has approximately 55,000 employees in more than 100 countries, all committed to making the potential of Human Data Science a reality, and we are actively hiring.

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