What are the responsibilities and job description for the Bioanalytical Principal Investigator - Dose Formulation position at Celerion?
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!
Location: Corporate office in Lincoln, NE. Just south of downtown. This role is on-site and requires candidates who are local to the Lincoln area.
As a Bioanalytical Principal Investigator, you will have overall responsibility for the technical conduct of the bioanalytical portion of studies.
\n- 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
- Provide analytical support for dose formulation testing
- Work with a highly motivated team to provide real-time results to support clinical operations
- Oversight of Event Investigation reports
- Minimum of a Bachelors 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
- Ability to work in a fast-paced environment with tight deadlines
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
