Senior Director, Biologics Analytical Research & Development

Role Summary

The Senior Director, Biologics Analytical R&D leads the Biologics Analytical R&D organization in Lake Couny to support AbbVie's early-stage biologics pipeline, including mAbs, shuttled-mAbs, Bi- and multi-specifics, genetic medicines (AOCs), ADCs, peptides, fusion proteins, and future modalities, paired with formulation development support for traditional, high-concentration, and complex formulations.

This role leads the development of industry-leading analytical methods, characterization packages, and control strategies to advance drug substance and drug product manufacturing, conjugation, formulation, and process development from Discovery Research through late-stage clinical development, and partners cross-functionally to drive manufacturing processes and formulation selection by providing key analytical data and insights.

The Senior Director ensures that all analytical deliverables are achieved within set timelines, budgets, and regulatory frameworks, while integrating analytical and program strategies into broader business objectives. The role drives top-tier analytical method development and validation strategies, implementation of new technologies, and automation, and establishes collaborative relationships to define successful process development strategies for biologics drug intermediate, drug substance, drug product, and novel drug delivery development (e.g., hyaluronidase). It also manages Discovery Research and Operations interfaces to ensure seamless transition of research programs into clinical development and technology transfers to commercial manufacturing and testing sites, and partners with global Analytical R&D peers to benchmark strategies and leverage best practices.

The Senior Director will develop Bio-ARD Lake County into a fully integrated Bio-ARD site by building cell-based bioassay capabilities in Lake County.

Responsibilities

• Provide leadership and talent development for > 50 highly skilled analytical and pharmaceutical scientists at the AbbVie Abbott Park and North Chicago sites
• Define and communicate industry-leading analytical strategies for complex biologics
• Responsible for development, validation and transfer of analytical methods aligned with global strategies
• Establish industry-leading biologics analytical characterization capabilities to support process development, formulation design and comparability
• Drive fundamental understanding of CQAs, degradation mechanisms and product/excipient interactions
• Manage departmental budget, analytical laboratories and equipment
• Balance resources, resolve issues and achieve target timing for pipeline projects and key strategic initiatives
• Drive technical excellence and innovations in science that improve the capabilities and productivity of the organization
• Work collaboratively across R&D and Operations to align and influence a broad range of development strategies that directly support drug development programs
• Manage and develop scientific talent across multiple disciplines and/or projects to address current and future business needs
• Ensure scientific excellence and foster functional, scientific, and professional development of staff
• Identify, evaluate, and propose both internal and external collaborations to drive scientific innovation and shared learning
• Accountable for compliance with Environmental Health and Safety regulations for the group
• Solves difficult and highly complex technical issues in an evolving regulatory climate

Qualifications

• PhD with at least 10 years of relevant pharma/biotech industry experience or master's degree with at least 15 years of pharma/biotech experience.
• Proven experience leading a biologics development organization with a range of experience levels and scientific disciplines
• Demonstrated record of success leading strategic initiatives and new technology evaluation/implementation
• Strong oral and written communication skills.
• Experience motivating and maintaining positive morale of highly skilled technical individuals and teams in an environment where compliance to standard procedures is required.
• Solid understanding of the various scientific disciplines needed for therapeutic biologics development (including analytical, drug substance development, drug product development, combination product development, manufacturing, QA, supply chain, regulatory).
• Strong negotiating, influencing, and leadership skills
• Entrepreneurial thinker capable of driving innovative ideas and making smart business decisions.