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Bioanalytical Principal Investigator - Small Molecule

Celerion

  • Lincoln, Nebraska
  • 20 days ago

    Highlights

    We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. Note: To make sure you don't miss important updates from us, please check your Spam folder for emails from @celerion.com, particularly interview invitations.

    Numbers & Facts

    LocationLincoln, Nebraska
    IndustryBiotechnology/Pharmaceuticals
    Company Size1,000 to 1,499 employees
    Websitehttps://celerion.com/

    Description

    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.
    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
    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.

    Note: To make sure you don't miss important updates from us, please check your Spam folder for emails from @celerion.com, particularly interview invitations. If you find one there, mark it as "Not Junk" to ensure future Celerion emails land in your inbox. Please note that Gmail accounts have been particularly noted as routing to Spam.

    We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

    Benefits

    401K

    About Company

    We Are Celerion

    Our 40+ years of experience, innovative strategies, global capabilities, and expertise in early phase research make us faster than our competitors. That means you get key data sooner, enabling you to make earlier go/no-go decisions about your drug's development. It’s all in the name: Celerion is derived from the Latin celeritas (meaning swiftness and speed), which reflects our founding principle—that fast, reliable research is vital to a product's success.

    Celerion’s focus is on the implementation of innovative strategies to generate key data very early to enable go/no-go decisions in drug development. With a large clinical capacity of more than 600 beds, efficient bioanalytical laboratories and experienced scientific staff, Celerion offers one of the most experienced clinical pharmacology research networks in the industry.

    Why Join Celerion?

    Celerion is one of the most experienced and successful CROs in the world. One of our key assets and greatest resources is the experience and expertise of our employees. Our vision to be the premier provider of early stage drug development solutions will only be achieved by ensuring that we have the brightest minds in the industry working with us.

    We are looking for individuals who enjoy working in a fast-paced environment and who demonstrate leadership, teamwork, and are passionate about what they do.

    If you want to build a meaningful career in a successfully growing company, and make a positive contribution to the health and well-being of people around the world, join our team.

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