Biologics Analytical Lead — Principal Scientist

Allergan; South San Francisco (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

AbbVie Biologics ARD in South San Francisco seeks an Analytical Lead to own analytical development strategy for biologic programs. You will coordinate method development, validation, and testing across internal labs and CROs, while preparing regulatory submission content and reports.

This on-site role requires collaboration with cross-functional teams, strong project management, and deep experience with protein therapeutics, including antibodies and ADCs.

Qualifications

• PhD/MS/BS with extensive industry experience in analytical development for biologics.
• Experience with analytical methods for release, stability, and characterization of protein therapeutics.
• Ability to author INDs/IMPDs and respond to health authority queries.

Responsibilities

• Own analytical development strategy for assigned biologic programs.
• Coordinate method development, validation, transfer, and testing across internal and external labs.
• Prepare and review regulatory submission content and technical reports.
• Communicate strategy, risks, and issues to teams and management.
• Plan resources and budgets for programs.

Skills

HPLC

Mass spectrometry

ELISA

Capillary electrophoresis

CD

DSC

Light scattering

Statistical design of experiments

Regulatory submissions

JMP

Education

PhD with 6+ years

MS with 12+ years

BS with 14+ years

Tools

JMP

Job description

AbbVie Biologics ARD in South San Francisco seeks an Analytical Lead to own analytical development strategy for biologic programs. You will coordinate method development, validation, and testing across internal labs and CROs, while preparing regulatory submission content and reports.

This on-site role requires collaboration with cross-functional teams, strong project management, and deep experience with protein therapeutics, including antibodies and ADCs.