Biologics Analytical R&D Scientist I – GMP/CMC Focus

AbbVie Inc.; Irvine (CA); On-site; USD 75,000 - 143,000; Full time

Job summary

AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) in Irvine is an analytical sciences group focused on early-stage CMC analytics for AbbVie biologics. The team develops methods to characterize biologics and supports cross-functional projects in a dynamic, regulated setting.

We seek candidates with strong GxP experience to uphold GMP principles, perform separations (HPLC, CE) and compendial tests, and contribute to interdisciplinary problem solving in a fast-paced

Qualifications

• Bachelor’s degree with 3+ years or Master degree with up to 2 years in a GxP-regulated environment.
• Experience with separation methods for biologics (HPLC, CE) in a cGMP setting.
• Strong communication and ability to present technical data to diverse teams.

Responsibilities

• Work in GMP-compliant areas including biosafety level 2 environments.
• Adhere to GMP and compendial guidelines and ensure quality standards.
• Execute separation and testing of materials using HPLC, CE, and related techniques.
• Review methods and SOPs for GMP compliance and accuracy.
• Collaborate with cross-functional Biologics Development teams and external departments.
• Maintain notebooks and summarize results; communicate observations clearly.
• Ensure safety, quality, data integrity and regulatory compliance in lab activities.

Skills

GMP knowledge

HPLC methods

Capillary electrophoresis

Data integrity

Scientific communication

GxP compliance

Education

Bachelor’s degree with 3+ years or Master with up to 2 years in a GxP-regulated environment

Bachelor’s or Master’s degree with 5+ years or 2+ years in a GxP-regulated environment

Job description

AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) in Irvine is an analytical sciences group focused on early-stage CMC analytics for AbbVie biologics. The team develops methods to characterize biologics and supports cross-functional projects in a dynamic, regulated setting.

We seek candidates with strong GxP experience to uphold GMP principles, perform separations (HPLC, CE) and compendial tests, and contribute to interdisciplinary problem solving in a fast-paced