Biologics Analytical Scientist – GMP & CMC Research

AbbVie; Irvine (CA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Job summary

AbbVie Biologics Analytical Research & Development in Irvine seeks candidates for BLA-like analytical roles focusing on GMP-compliant methods for biologics. You will join a team performing separation and compendial testing (HPLC, CE, icIEF) in a cGMP environment and contribute to method development and data integrity.

Responsibilities include reviewing SOPs, collaborating with cross-functional teams, and maintaining rigorous documentation while upholding safety and regulatory standards.

Qualifications

• Bachelor’s or Master’s degree in a relevant field.
• Experience in a GxP-regulated environment is preferred.
• Strong understanding of GMP/GxP principles and regulatory expectations.
• Experience with separation methods for biologics (HPLC, CE, CE-based methods) in a cGMP environment.

Responsibilities

• Adhere to GMP, USP/EP/JP guidelines and ensure quality analytical data.
• Review methods, protocols and SOPs for GMP compliance.
• Collaborate with cross-functional teams to provide scientific expertise and solutions.
• Maintain reagents and notebooks, summarize results, and report observations clearly.
• Ensure laboratory activities comply with safety, quality, and regulatory requirements.

Skills

GMP compliance

HPLC

Capillary electrophoresis

Data integrity

Scientific communication

GxP knowledge

Education

Bachelor's or Master’s degree in a relevant field

Advanced degree (MS/PhD) in a relevant field

Tools

HPLC (RP/SEC/AEX/CEX)

Capillary electrophoresis

icIEF

GxP software/tools

Job description

AbbVie Biologics Analytical Research & Development in Irvine seeks candidates for BLA-like analytical roles focusing on GMP-compliant methods for biologics. You will join a team performing separation and compendial testing (HPLC, CE, icIEF) in a cGMP environment and contribute to method development and data integrity.

Responsibilities include reviewing SOPs, collaborating with cross-functional teams, and maintaining rigorous documentation while upholding safety and regulatory standards.