Biologics Analytics Scientist II — Bioassay Development

AbbVie Inc.; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie Inc. is seeking an experienced Scientist to develop and validate analytical methods for biologics.

The role focuses on early development of complex bioassays to understand kinetics and mechanisms of action, working independently to plan experiments and generate data for regulatory filings. The candidate will support formulation, stability studies, and technical report writing, maintaining compliance with biosafety and company requirements.

Qualifications

• BS or MS with related field and several years of hands-on experience in biologics assay development.
• Experience in developing, validating and transferring analytical methods for biologics under regulated environments.
• Strong understanding of quality systems and regulatory expectations in biotech development.

Responsibilities

• Develop and validate analytical methods for biopharmaceuticals, including ELISA, qELISA and other bioassays.
• Develop and optimize bioassays and functional assays to assess biological activity and product attributes.
• Prepare technical reports, SOPs and transfer methods to other sites or teams as needed.
• Collaborate with cross-functional teams to design experiments and interpret data for regulatory filings.

Skills

Bioassay development

ELISA

TR-FRET

AlphaLISA

Bioanalytical methods

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in bioscience

Master's degree in bioscience

Tools

qELISA

Enzyme activity assays

Job description

AbbVie Inc. is seeking an experienced Scientist to develop and validate analytical methods for biologics.

The role focuses on early development of complex bioassays to understand kinetics and mechanisms of action, working independently to plan experiments and generate data for regulatory filings. The candidate will support formulation, stability studies, and technical report writing, maintaining compliance with biosafety and company requirements.