Senior Director, Analytical Research

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Director will be responsible for leading the Synthetic Molecule (SM) Analytical R&D organization in Lake County supporting AbbVie's innovative and unique early stage pipeline which includes small molecule, peptides, ADCs (antibody-drug conjugates), APCs (antibody-peptide conjugates), LNP (Lipid Nanoparticle), and future modalities paired with formulation development support for conventional (e.g. OSD, injectables) and complex formulations (e.g. Long Acting Injectables, co-formulations).

This individual will lead the organization to develop industry-leading analytical methods, analytical characterization packages, and control strategies to advance the manufacturing, purification, formulation, and process development for drug intermediates, Drug Substance and Drug Products from Discovery Research through late-stage clinical development. The Senior Director will advance fundamental understanding of novel synthetic modalities and their degradation mechanisms during manufacturing, shelf-life, distribution, and administration. He/she 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 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 drug intermediate, drug substance, drug product and novel drug delivery development.  He/she 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 will also partner with global Analytical R&D peer organizations working to advance similar Synthetic modalities to benchmark strategies and technologies and leverage analytical best practices.

Responsibilities:

• Provide leadership and talent development for > 50 highly skilled analytical and pharmaceutical scientists at the AbbVie Abbott Park, North Chicago, and Ludwigshafen Germany sites
• Define and communicate industry-leading analytical strategies for complex modalities
• Responsible for development, validation and transfer of analytical methods aligned with global strategies
• Establish industry-leading 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 regulatio