Sr. Director, Analytical

AbbVie•North Chicago, IL

About The Position

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.

Requirements

PhD with at least 15 years of relevant pharma/biotech industry experience or master's degree with at least 20 years of pharma/biotech experience.
Proven experience leading an Analytical 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 with standard procedures is required.
Solid understanding of the various scientific disciplines needed for therapeutic 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.

Nice To Haves

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)
advancing fundamental understanding of novel synthetic modalities and their degradation mechanisms during manufacturing, shelf-life, distribution, and administration
partner cross-functionally to drive robust drug substance and drug product manufacturing processes and formulation selection by providing key analytical data and insights
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
drive top-tier analytical method development and validation strategies, implementation of new technologies, and automation
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
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
partner with global Analytical R&D peer organizations working to advance similar Synthetic modalities to benchmark strategies and technologies and leverage analytical best practices
Team size: 50+
Number of programs supported: 20+
Recent additional responsibilities: peptides, LNP

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 regulations for the group.
Solves difficult and highly complex technical issues in an evolving regulatory climate.