AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic products.
Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch.
We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines.
Careers in AbbVie Biologics ARD provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.
The Analytical Development-Early Stage group within Biologics ARD is responsible for support of programs that are preparing for FIH clinical studies.
The team leads Stage 1 method development, optimization, and validation.
In collaboration with cross-functional partners, the team supports early phase formulation and process development studies.
Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application submission content.
Key Responsibilities
Analytical characterization and assessment of process/formulation development samples and clinical trial supplies (e.
g.
GMP compliant stability and release testing)
Provide process development support with fast turnaround to enable clinical material manufacturing.
May require occasional off-hours support.
Design and execute experiments for method development and validation studies with supervision.
Documents experimental data appropriately in laboratory documentation system and technical memos; contributes to writing technical reports.
Maintains laboratory equipment and optimize laboratory operations for efficient use of time and resources.
Troubleshoots equipment and experimental problems.
Assists in continuous improvement activities.
Responsible for compliance with all applicable AbbVie policies and procedures.
Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
Qualifications:
BS (2+ years) or MS (0-2 years) in scientific discipline (e.
g.
, Chemistry, Biochemistry, or Biology) with previous laboratory experience.
Experience in analytical methodology, such as chromatography, KF, UV and compendial methods.
Experience in bioanalytical techniques preferred (IEX, HIC, SEC, CGE, icIEF, particle imaging, ELISA).
Experienced in laboratory systems (LIMS, CDS, ELN) preferred.
Experience in Microsoft Office (Excel, Power Point, and Word) required.
Key AbbVie Competencies:
Builds strong relationships with peers and cross functionally with partners outside of teams 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.
*Level and compensation will be commensurate with experience.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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