Location: Corporate office in Lincoln, NE. Just south of downtown.
As a Bioanalytical Principal Investigator, you will have overall responsibility for the technical conduct of the bioanalytical portion of studies. This role is with our Small Molecule team.
Essential Functions:- Serve as primary client contact for the bioanalytical segment of studies
- Review protocol and assure study is conducted in accordance with Protocol
- Document and report any deviations from the protocol to Study Director or Sponsor
- Review and approve Sample Analysis Plans
- Assure all experimental data is accurately recorded and verified
- Assure corrective action is taken and documented when necessary
- Review and approve all project-related QA audits
- Approve and document any bioanalytical deviations
- Review and approve all bioanalytical reports
- Assure all study personnel have adequate training, education and experience to perform required study functions
- Conduct impact analysis of bioanalytical deviations
- Oversight of Event Investigation reports
Requirements:- Minimum of a Bachelor's degree or equivalent in a science-related field with 5 or more years of industry experience preferred
- 5 or more years of previous laboratory and/or regulated bioanalysis knowledge preferred
- Proficiency with computers
- Excellent oral and written skills
Celerion Values: Integrity Trust Teamwork Respect