Senior Director, Analytical Research
About the Company
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.
About the Role
The Senior Director will lead 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 develop industry-leading analytical methods, characterization packages, and control strategies to advance manufacturing, purification, formulation, and process development for drug intermediates, Drug Substance, and Drug Products from Discovery Research through late-stage clinical development. The role involves advancing fundamental understanding of novel synthetic modalities and their degradation mechanisms during manufacturing, shelf-life, distribution, and administration.
The Senior Director will partner cross-functionally to drive robust drug substance and drug product manufacturing processes and formulation selection by providing key analytical data and insights. They will ensure all analytical deliverables are achieved within set timelines, budgets, and regulatory frameworks while integrating analytical and program strategies into broader business objectives.
Responsibilities
- Provide leadership and talent development for over 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 to improve organizational capabilities and productivity.
- Work collaboratively across R&D and Operations to align and influence a broad range of development strategies supporting 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.
- Solve difficult and highly complex technical issues in an evolving regulatory climate.
Qualifications
- 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 requiring compliance with standard procedures.
- 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.
Team size: 50+ | Number of programs supported: 20+ | Additional responsibilities include peptides and LNP.
Pay
The compensation range described is the range of possible base pay that AbbVie believes in good faith it will pay for this role at the time of posting, based on the job grade. Individual compensation paid within this range will depend on many factors, including geographic location. This range may be modified in the future. AbbVie offers a comprehensive package of benefits, including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) to eligible employees. This job is eligible to participate in long-term incentive programs.
Benefits
- Paid time off (vacation, holidays, sick leave).
- Medical, dental, and vision insurance.
- 401(k) retirement plan.
- Eligibility to participate in long-term incentive programs.