Biologics Analytical Development Scientist II

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

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking an experienced Scientist to develop and validate bioassays for biologics in CMC development. The role emphasizes planning experiments, independently performing multiple analytical methods, and ensuring regulatory compliance in a collaborative lab environment.

The candidate will also support biologics process development, formulation, and stability studies, with data compilation for regulatory filings and writing of technical reports or SOPs as needed.

Qualifications

• BS or equivalent education with typically 7+ years of experience or MS or equivalent education with typically 5+ or more years of experience, is required.
• Advanced knowledge and experience in developing, validating and transferring methods for biologics, including qELISA (quantitative), Potency Assays, enzyme activity assays and other bioassays.
• Solid understanding of production and characterization of biopharmaceuticals in a regulated environment is expected.
• Understanding in CMC development strategy of biologics drugs is expected.

Responsibilities

• Support development of phase appropriate methods to support biologics development programs.
• Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals. Create written procedures and protocols.
• Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals, including assay development for protein mass determination.
• Develop and optimize bioassays and functional assays, including ELISA, TR-FRET, AlphaLISA, and related assay platforms.
• Support the development of assays that assess biological activity, potency, mechanism of action, and relevant product attributes.
• Actively participate on cross-functional teams within Biologics Development and provide support to external departments.

Skills

Bioassays

ELISA

TR‑FRET

AlphaLISA

Education

BS or equivalent

MS or equivalent

Tools

qELISA

Potency assays

Enzyme activity assays

Job description

AbbVie is seeking an experienced Scientist to develop and validate bioassays for biologics in CMC development. The role emphasizes planning experiments, independently performing multiple analytical methods, and ensuring regulatory compliance in a collaborative lab environment.

The candidate will also support biologics process development, formulation, and stability studies, with data compilation for regulatory filings and writing of technical reports or SOPs as needed.