AbbVie Senior Scientist I in Bioanalytics managing projects and studies throughout the bioanalytical lifecycle in a regulated environment. Oversees sample analysis, data review, and report writing for GLP non-clinical and clinical studies.
Responsibilities
Overseeing sample analysis of Abbvie assets in support of nonclinical and clinical trials according to regulatory requirements.
Managing internal and external stakeholders on deliverables and priorities
Maintain awareness of evolving trends in separations and mass spectrometry
Maintain and troubleshoot complex LC systems and ultra-sensitive mass spectrometers
Author and approve method documents for regulated analysis and scientific papers for publication
Expertise in the cutting-edge assay technologies and excellent assay troubleshooting skills
Qualification
PhStrong interpersonal skillsKey Leadership CompetenciesLearns fast
Required
Ph.D. with zero years’ experience, M.S. with 8 years, or B.S. with 10+ years of pharma or CRO experience and a degree in Analytical Chemistry or related field required.
Experience with regulated bioanalysis support in the drug development process.
Experience with regulatory guidelines for bioanalysis and experience working in a regulated environment (ALCOA principles).
Experience developing and validating bioanalytical methods for small molecules, large molecules, and peptides.
Experience with operating AB Sciex triple quadrupole mass spectrometers or equivalents (ex: 5500, 6500, 7500).
Experience with electronic laboratory notebook software, WATSON Laboratory Information Management Software (LIMS), and AB Sciex Analyst/Sciex OS Software.
Experience with operating Shimadzu Liquid Chromatography instruments or equivalents.
Experience with Hamilton Starlet automated liquid handling instruments is a plus.
Strong interpersonal skills, the ability to work independently with minimal supervision in managing multiple projects and priorities and work well within a team, and a desire to learn specific techniques for bioanalysis.
Key Leadership Competencies:
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
Learns fast, grasps the "essence" and can change course quickly where indicated.
Preferred
Experience with Hamilton Starlet automated liquid handling instruments
