Bioanalytical Principal Investigator - Dose Formulation
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. Essential Functions:Serve as primary client contact for the bioanalytical segment of studiesReview protocol and assure study is conducted in accordance with ProtocolDocument and report any deviations from the protocol to Study Director or SponsorReview and approve Sample Analysis PlansAssure all experimental data is accurately recorded and verifiedAssure corrective action is taken and documented when necessaryReview and approve all project-related QA auditsApprove and document any bioanalytical deviationsReview and approve all bioanalytical reportsAssure all study personnel have adequate training, education and experience to perform required study functionsConduct impact analysis of bioanalytical deviationsProvide analytical support for dose formulation testingWork with a highly motivated team to provide real-time results to support clinical operationsOversight of Event Investigation reportsRequirementsMinimum of a Bachelors degree or equivalent in a science-related field with 5 or more years of industry experience preferred5 or more years of previous laboratory and/or regulated bioanalysis knowledge preferredProficiency with computers Excellent oral and written skills Ability to work in a fast-paced environment with tight deadlinesCelerion 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.
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. Essential Functions:Serve as primary client contact for the bioanalytical segment of studiesReview protocol and assure study is conducted in accordance with ProtocolDocument and report any deviations from the protocol to Study Director or SponsorReview and approve Sample Analysis PlansAssure all experimental data is accurately recorded and verifiedAssure corrective action is taken and documented when necessaryReview and approve all project-related QA auditsApprove and document any bioanalytical deviationsReview and approve all bioanalytical reportsAssure all study personnel have adequate training, education and experience to perform required study functionsConduct impact analysis of bioanalytical deviationsProvide analytical support for dose formulation testingWork with a highly motivated team to provide real-time results to support clinical operationsOversight of Event Investigation reportsRequirementsMinimum of a Bachelors degree or equivalent in a science-related field with 5 or more years of industry experience preferred5 or more years of previous laboratory and/or regulated bioanalysis knowledge preferredProficiency with computers Excellent oral and written skills Ability to work in a fast-paced environment with tight deadlinesCelerion 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.
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