Biologics Analytical Scientist I — GMP/R&D

AbbVie; Irvine (CA); On-site; USD 70,000 - 120,000; Full time

Job summary

AbbVie Biologics Analytical Research & Development in Irvine seeks candidates for biologics analytical roles. The team conducts early-stage CMC analytical activities and uses HPLC, capillary electrophoresis and compendial techniques to characterize biologics.

You will work with cross-functional teams to advance development strategies while maintaining strict GMP standards. The position requires handling select agents in regulated labs and maintaining rigorous data integrity, safety, and quality

Qualifications

• Requires a Bachelor’s degree in a relevant field with 3+ years of experience or Master’s with 2+ years in a GxP-regulated environment.
• Strong understanding of GMP, compendial methods (USP/EP/JP) and regulatory expectations.
• Experience executing separation methods for biologics (HPLC, CE, CEX, CEX) in a cGMP environment.

Responsibilities

• Adhere to GMP guidelines and quality standards in analytical testing of biologics.
• Review methods, SOPs and protocols for GMP compliance.
• Collaborate with cross-functional Biologics Development teams and external departments to solve problems.

Skills

GMP knowledge

HPLC methods

Capillary electrophoresis

Data integrity

Cross-functional collaboration

Education

Bachelor's degree in a related field

Master's degree in a related field

Tools

HPLC

Capillary electrophoresis

GxP testing

Job description

AbbVie Biologics Analytical Research & Development in Irvine seeks candidates for biologics analytical roles. The team conducts early-stage CMC analytical activities and uses HPLC, capillary electrophoresis and compendial techniques to characterize biologics.

You will work with cross-functional teams to advance development strategies while maintaining strict GMP standards. The position requires handling select agents in regulated labs and maintaining rigorous data integrity, safety, and quality