Senior Director, Biologics Analytical Research & Development

AbbVie•North Chicago, IL

About The Position

Overview: The Senior Director will be responsible for leading the Biologics Analytical R&D organization in Lake Couny supporting AbbVie's innovative and unique early stage biologics pipeline which includes mAbs, shuttled-mAbs, Bi- and multi-specifics, genetic medicines (AOCs), ADCs (antibody-drug conjugates), multi-specifics, peptides, fusion proteins and future biologics modalities paired with formulation development support for traditional, high concentration, and complex formulations. This individual will lead the organization to develop industry-leading analytical methods, analytical characterization packages, and control strategies to advance the manufacturing, conjugation, formulation, and process development for drug intermediates, Drug Substance and Drug Product biologics from Discovery Research through late-stage clinical development. The Senior Director will advance fundamental understanding of novel biological modalities and their degradation mechanisms during manufacturing, shelf-life, distribution, and administration. He/she/they will partner cross-functionally to drive robust drug substance and drug product manufacturing processes and formulation selection by providing key analytical data and insights. The Senior Director will ensure that all analytical deliverables are achieved within set timelines, budgets, and regulatory frameworks, while seamlessly integrating analytical and program strategies into broader business objectives. He/she/they will drive top-tier analytical method development and validation strategies, implementation of new technologies, and automation. The Senior Director will establish collaborative and productive working relationships with key partner organizations to define successful process development strategies for biologics drug intermediate, drug substance, drug product and novel drug delivery development ( e.g. hyaluronidase). He/she/they will effectively manage Discovery Research and Operations interfaces to ensure seamless transition of research programs into clinical development and technology transfers to commercial manufacturing and testing sites. He/she/they will also partner with global Analytical R&D peer organizations working to advance similar biologics modalities to benchmark strategies and technologies and leverage analytical 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 (LC).

Requirements

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.

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.