Senior Director, Biologics Analytical Research & Development

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.

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).

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.

• 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.

Team size LC: 50+

Number of programs supported out of LC: 20+

Recent additional responsibilities: AOCs, peptides, bioassay

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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