Associate BioServices Project Manager
The Assoc. BioServices Project Manager is the primary point of contact for our external customers. The focus of the Assoc. BioServices Project Manager is to provide exceptional customer service while ensuring that all work meets Q2 Solutions scientific standards working under the direction of senior members of the BioServices Project Management team.
- Provide oversight and conduct of a project throughout its life at Q2 Solutions, including method development, method validation, and sample analysis.
- 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 SOP.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Ability to achieve results through collaborative efforts with others.
- Understanding of liquid chromatography and combination with mass spectrometry
- 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 follow verbally communicated procedures
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s Degree in a scientific field with 3 years’ related experience; or equivalent combination of education, training and experience in GLP laboratory environment.
- 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.
EEO Minorities/Females/Protected Veterans/Disabled
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