Skip to main contentA logo with &quat;the muse&quat; in dark blue text.
Quintiles

Immunoassay Bioanalytical Project Manager

PURPOSE

The BioServices Project Manager is the primary point of contact and principal investigator for our external customers. The focus of the BioServices Project Manager is to provide exceptional customer service while ensuring that all work meets Q2 Solutions scientific standards.

RESPONSIBILITIES

  • Provide oversight and conduct of a project 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 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 Q2 Solutions SOP

Want more jobs like this?

Get jobs delivered to your inbox every week.

By signing up, you agree to our Terms of Service & Privacy Policy.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • 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.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor’s Degree in Biology, Biochemistry, or related scientific field with 5 years’ related experience; or equivalent combination of education, training and experience in GLP laboratory environment.

PHYSICAL REQUIREMENTS

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

Job ID: 53c59fb7cfd58dfe3b6de4dc6be9b428
Employment Type: Other

This job is no longer available.

Search all jobs