Associate, Scientist II, Analytical Development (Biologics)

Role Summary

Associate, Scientist II, Analytical Development (Biologics) within AbbVie Biologics ARD, supporting early-stage programs preparing for First-In-Human (FIH) studies. Responsible for stage 1 method development, optimization, and validation; collaboration on early-phase formulation and process development; generating data packages to drive product and process understanding and supporting clinical materials release testing and stability studies.

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.

Skills

• 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.