Bioanalytical Principal Investigator - Small Molecule

Celerion; Lincoln (NE); On-site; USD 95,000 - 150,000; Full time

Job summary

Celerion is seeking a Bioanalytical Principal Investigator to lead the bioanalytical portion of clinical studies from our Small Molecule team. Located at our corporate office in Lincoln, NE, the role focuses on technical conduct and client coordination.

Essential duties include protocol review, data integrity, QA oversight, staff training, and generation of bioanalytical reports. Candidates should have a Bachelor's degree in a science field and 5+ years of industry experience with strong

Qualifications

• Bachelor's degree in a science-related field with 5+ years of industry experience preferred.
• 5+ years of laboratory and/or regulated bioanalysis knowledge preferred.
• Excellent oral and written communication skills.

Responsibilities

• Serve as primary client contact for the bioanalytical segment of studies.
• Review protocol and assure study is conducted in accordance with Protocol.
• Document deviations and report to Study Director or Sponsor.
• Review and approve Sample Analysis Plans and QA audits.
• Ensure data is accurately recorded and verified and corrective actions taken when necessary.
• Oversee training of study personnel and conduct impact analysis of deviations.
• Oversee Event Investigation reports and biosample reporting.

Skills

Bioanalytical expertise

Excellent communication

Computer literacy

Education

Bachelor's degree in science-related field

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 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

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