Senior Scientist I - Bioanalytics
About The Position
The Senior Scientist I will work in the Regulated Bioanalysis group within the Quantitative, Translational, and ADME Sciences (QTAS) department. The position acts as a Principal Investigator managing projects and studies throughout the bioanalytical lifecycle, including bioanalytical sample analysis, data review, and report writing for GLP non-clinical and clinical studies. The role requires experience managing bioanalytical operational workflows in a regulated environment and collaboration across QTAS, Preclinical Safety, and Clinical Pharmacology. The role oversees sample analysis for AbbVie assets supporting nonclinical and clinical trials in accordance with regulatory requirements; manages internal and external stakeholders, deliverables, and priorities; maintains awareness of developments in separations and mass spectrometry; maintains and troubleshoots complex LC systems and ultra-sensitive mass spectrometers; and authors and approves method documents for regulated analysis and scientific papers. Expertise in advanced assay technologies and strong assay troubleshooting skills are expected.
Requirements
- Ph.D. with zero years of experience, M.S. with 8 years of experience, or B.S. with 10 or more years of pharma or CRO experience, and a degree in Analytical Chemistry or a related field.
- Experience supporting regulated bioanalysis in the drug development process.
- Experience with regulatory guidelines for bioanalysis and working in a regulated environment, including ALCOA principles.
- Experience developing and validating bioanalytical methods for small molecules, large molecules, and peptides.
- Experience operating AB Sciex triple quadrupole mass spectrometers or equivalents, such as 5500, 6500, or 7500 models.
- Experience with electronic laboratory notebook software, WATSON Laboratory Information Management Software (LIMS), and AB Sciex Analyst/Sciex OS Software.
- Experience operating Shimadzu Liquid Chromatography instruments or equivalents.
- Strong interpersonal skills.
- Ability to work independently with minimal supervision while managing multiple projects and priorities.
- Ability to work well within a team and desire to learn specific techniques for bioanalysis.
Nice To Haves
- Experience operating Hamilton Starlet automated liquid handling instruments.
Responsibilities
- Act as a Principal Investigator to manage projects and studies throughout the bioanalytical lifecycle.
- Oversee bioanalytical sample analysis for AbbVie assets supporting nonclinical and clinical trials according to regulatory requirements.
- Perform or manage data review and report writing for GLP non-clinical and clinical studies.
- Manage internal and external stakeholders, 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.
- Apply expertise in advanced assay technologies and troubleshoot assays.
- Work cross-functionally within QTAS and with Preclinical Safety and Clinical Pharmacology.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
