Biologics Analytical Lead: CMC Strategy & Delivery

AbbVie; South San Francisco (CA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Long-term incentives

Job summary

AbbVie Biologics ARD in South San Francisco, CA, seeks an Analytical Lead to own analytical development strategy for assigned biologic programs. You will coordinate method development, validation, transfer, and testing across internal labs and external contract labs, supporting multi-specifics, antibodies, ADCs, and novel modalities.

You will lead cross-functional teams, author regulatory content, and drive timely delivery of analytics to enable CMC milestones in a fast-paced, on-site

Qualifications

• PhD/MS/BS with extensive experience in analytical development of biologics.
• Experience authoring INDs/IMPDs and regulatory responses.
• Knowledge of release, stability, and characterization for protein therapeutics.

Responsibilities

• Own analytical development strategy for assigned programs, including CQAs and stability studies.
• Coordinate method development, validation, and transfer across labs.
• Oversee third-party labs to ensure quality and timeliness.
• Prepare regulatory submission content and responses to health authorities.
• Communicate strategy and risks to management and SMEs.
• Lead project updates and resource planning for analytics.

Skills

Analytical development

CMC strategy

Project management

IND/IMPD writing

GXP compliance

Statistical analysis

Education

PhD with 6+ years

MS with 12+ years

BS with 14+ years

Tools

JMP

Job description

AbbVie Biologics ARD in South San Francisco, CA, seeks an Analytical Lead to own analytical development strategy for assigned biologic programs. You will coordinate method development, validation, transfer, and testing across internal labs and external contract labs, supporting multi-specifics, antibodies, ADCs, and novel modalities.

You will lead cross-functional teams, author regulatory content, and drive timely delivery of analytics to enable CMC milestones in a fast-paced, on-site