Senior Scientist I - Bioanalytics

BioSpace; North Chicago (IL); On-site; USD 140,000 - 180,000; Full time

Job summary

AbbVie is seeking a Senior Scientist in the Regulated Bioanalysis group within QTAS. You will act as Principal Investigator, manage bioanalytical studies from analysis through reporting, and ensure compliance with GLP and regulatory guidelines.

You will lead workflows, collaborate with Preclinical Safety and Clinical Pharmacology, and mentor junior staff in cutting-edge assay technologies.

Qualifications

• PhD with zero years or MS with 8+ years or BS with 10+ years pharma/CRO experience.
• Experience with regulated bioanalysis in drug development.
• Familiarity with ALCOA principles and regulatory guidelines.
• Experience developing and validating bioanalytical methods for small/large molecules.
• Operating high-end LC-MS systems and related software.

Responsibilities

• Overseeing sample analysis for nonclinical and clinical trials.
• Manage internal and external stakeholders on deliverables and priorities.
• Maintain awareness of trends in separations and mass spectrometry.
• Troubleshoot complex LC systems and mass spectrometers.
• Author and approve method documents and publications.

Skills

Bioanalysis operations

Regulated environment

Data review

Report writing

Project management

Cross-functional collaboration

Education

PhD in Analytical Chemistry or related field

MS in Analytical Chemistry or related field

BS in Analytical Chemistry or related field

Tools

AB Sciex triple quadrupole MS

Shimadzu LC systems

Watson LIMS

Sciex Analyst/OS

Hamilton Starlet

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The candidate for this Senior Scientist position will be working in the Regulated Bioanalysis group in the Quantitative, Translational, and ADME Sciences (QTAS) department. The primary responsibility will be acting as a Principal Investigator to manage projects and studies throughout the bioanalytical lifecycle, which includes but not limited to bioanalytical sample analysis, data review, and report writing for GLP non-clinical and clinical studies. The candidate must be experienced with managing bioanalytical operation workflows in a regulated environment. The individual will also be expected to work cross functionality within QTAS and with Preclinical Safety and Clinical Pharmacology.

Key Responsibilities Include

• 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

Qualifications

• 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.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html