With close direction from the Director, BioServices, BioServices Project Manager, the BioServices Project Leader 1 will:
- Plan day to day activities for assigned projects.
- Create work lists for laboratory staff.
- Request samples from Laboratory Operations for analysis
- Provide daily direction and feedback to laboratory staff.
- Import and process run data in Watson. Accept or reject run results.
- Work with Project Manager to investigate failed runs and runs with analytical issues.
- Write up analytical results and assemble run binders.
- Submit accurate weekly assessment of resource requirements for scheduling purposes
- Attend weekly scheduling and revenue update meetings and provide updates on project progress
- Maintain run trackers for assigned projects.
- Provide timely MS timesheets for study tracking
- Review data (run binders, data tables, etc.) for regulatory compliance and scientific quality.
- Track supply and expiration of project related materials (LC columns, reference compounds, stock solutions, etc.).
- Assemble data tables for client submission
- Design validation experiments to direct wet lab staff.
- Archive all studies in a timely manner in accordance with Q2 Solutions SOP.
- Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Understanding of liquid chromatography and combination with mass spectrometry or In vitro and Immunoassay
- Understanding of sample extraction and routine laboratory procedures.
- Understanding of method development and validation of assays
- Ability to interact with internal clients, and work to objectives/timelines
- Excellent attention to detail and communication skills
- Ability to follow verbally communicated or draft procedures
- Ability to describe clearly experimental objectives and data conclusions
- 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 1 year of 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.