Senior Scientist I, Bioanalysis

Role Summary

The Senior Scientist will work in the Regulated Bioanalysis group in the Quantitative, Translational, and ADME Sciences (QTAS) department. The primary responsibility will be to manage projects throughout the bioanalytical lifecycle, including bioanalytical sample analysis, data review, and report writing for GLP non-clinical through clinical studies. The candidate must be experienced in developing and validating LC-MS based methods in a regulated environment. The individual will also be expected to work cross functionality within QTAS and with Preclinical Safety and Clinical Pharmacology.

Responsibilities

• Overseeing method development, validation and 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 method documents for regulated analysis and scientific papers for publication
• Expertise in the cutting-edge assay technologies and excellent assay troubleshooting skills

Qualifications

• Required: Bachelor’s Degree and typically 10 years of experience, OR Master’s Degree and typically 8 years of experience OR PhD and no experience necessary.
• Preferred: Ph.D. with three 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.
• Required: Experience with regulated bioanalysis support in the drug development process.
• Required: Experience with regulatory guidelines for bioanalysis and experience working in a regulated environment (ALCOA principles).
• Required: Experience developing and validating bioanalytical methods for small molecules, large molecules, and peptides.
• Required: Experience with operating AB Sciex triple quadrupole mass spectrometers or equivalents (ex: 5500, 6500, 7500).
• Required: Experience with electronic laboratory notebook software, WATSON Laboratory Information Management Software (LIMS), and AB Sciex Analyst/Sciex OS Software.
• Required: Experience with operating Shimadzu Liquid Chromatography instruments or equivalents.
• Preferred: Hamilton Starlet automated liquid handling instruments is a plus.
• Required: 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.