Director of Biologics Analytical Science

AbbVie Inc.; North Chicago (IL); Presencial; USD 180.000 - 260.000; Jornada completa

Descripción de la vacante

AbbVie Inc. in the United States is seeking a Director of Biologics Analytical within Product Development Science & Technology.

You will lead global analytical activities for NBEs, mAbs, ADCs, and gene therapies, guiding method development, validation, and technology transfer to support clinical and commercial programs. The role requires a track record of strategic leadership, regulatory interactions, and driving scientific innovations across biotech disciplines.

Formación

• PhD or Master’s with pharma/biotech leadership experience.
• Proven ability to lead a CMC development organization (analytical development, drug substance, parenteral).
• Analytical method development, transfer and troubleshooting for biologics; NDA/BLA experience.
• Extensive regulatory knowledge and interactions with agencies; NDA/BLA responsibilities.
• Cross-disciplinary expertise across analytical control strategies, formulation, QA, and supply chain.

Responsabilidades

• Provides leadership and strategic direction for analytical and pharmaceutical science groups.
• Defines and communicates analytical strategies for mAbs, multi-specifics, and ADCs.
• Partners with manufacturing and QC for process modernization and quality controls.
• Directs development, validation, and transfer of analytical methods supporting pipeline and lifecycle management.
• Leads collaboration with regulatory agencies for analytical development and regulatory filings.
• Oversees resources, timelines, and budget across programs; drives tech innovations.
• Fosters staff development and performance, ensuring scientific excellence.
• Interfaces with R&D and operations to align development strategies with drug programs.
• Evaluates internal and external collaborations to drive innovation.
• Ensures EH&S compliance for the group.

Conocimientos

Leadership

Regulatory affairs

Analytical development

Biologics

NDA/BLA experience

People management

Cross-functional leadership

Communication skills

Educación

PhD + 10+ yrs exp

Master's + 15+ yrs exp

Descripción del empleo

AbbVie Inc. in the United States is seeking a Director of Biologics Analytical within Product Development Science & Technology.

You will lead global analytical activities for NBEs, mAbs, ADCs, and gene therapies, guiding method development, validation, and technology transfer to support clinical and commercial programs. The role requires a track record of strategic leadership, regulatory interactions, and driving scientific innovations across biotech disciplines.