Celerion

Bioanalytical Principal Investigator - Ligand Binding

Celerion  •  Lincoln, NE (Onsite)  •  8 days ago
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Job 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 Large 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
  • 5 or more years of previous laboratory and/or regulated bioanalysis knowledge with an emphasis in ligand binding and/or immunogenicity 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.
Celerion

About Celerion

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.

With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings.

Our operations are strategically located in:

Lincoln, Nebraska (Corporate Headquarters)

Philadelphia, Pennsylvania

Phoenix, Arizona

Belfast, Northern Ireland,UK

Zurich, Switzerland

Vienna, Austria

Richmond, Virginia

Montreal, Quebec, Canada

For more information, visit: www.celerion.com

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Lincoln, NE
Year Founded
2010
Website
celerion.com
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