Director, Biologics Analytical

Job Description

AbbVie Product Development Science & Technology – Biologics Analytical is a global analytical organization responsible for all CMC analytical activities related to the clinical development, commercialization, and on-market support of AbbVie's biological products. Our scope includes AbbVie's diverse pipeline of New Biological Entities (NBEs), including monoclonal Antibodies (mAbs), multispecific antibodies, Antibody Drug Conjugates (ADCs), and gene therapies and spans from clinical development to commercial product support. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines and ensure the commercial manufacturing success.

The Director will be responsible for leading a diverse team supporting AbbVie's pipeline which includes monoclonal Antibodies (mAbs), multispecific antibodies, Antibody Drug Conjugates (ADCs), gene therapies and other biologic products. You will lead the groups to drive the development of industry-leading analytical methods and control strategies to advance pipeline programs from clinical development through commercial manufacturing. You will partner cross-functionally to drive robust development of drug substances, drug products and combination products by enforcing rigorous risk management, applying Quality by Design (QbD), and providing key analytical support and insights.

The 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. You will drive top-tier analytical method development and validation strategies, implementation of new technologies and automation. You will establish collaborative and productive working relationships with key partner organizations to define successful process development strategies. The Director will effectively manage interfaces to ensure seamless transition of research programs into late-stage clinical development and technology transfers to commercial manufacturing and testing sites.

Major Responsibilities:

• Provides leadership, strategic guidance and talent development for groups of highly skilled analytical and pharmaceutical scientists who are responsible for global development programs and commercial support across AbbVie global network.
• Defines and communicates industry-leading analytical strategies for mAbs, multi-specifics, ADCs and other potential new modalities.
• Familiar with commercial manufacturing and QC testing and able to be a partner in strategic initiatives in the commercial space for modernization of manufacturing and quality controls.
• Responsible for development, validation and transfer of analytical methods to support pipeline development and product life cycle management aligned with the strategies.
• Establishes industry-leading analytical capabilities to support CMC process development, technology transfer and post-approval changes.
• Solves difficult and highly complex technical issues in an evolving regulatory landscape.
• Balances resources, resolves issues and achieves target timing for pipeline projects and key strategic initiatives.
• Ensures scientific excellence and fosters functional, scientific, and professional development of staff.
• Leads interactions with regulatory agencies in analytical development area and delivers regulatory filing packages.
• Manages and develops scientific talent across multiple disciplines and/or projects to address current and future business needs.
• Drives technical excellence and innovations in science that improve the capabilities and productivity of the organization.
• Works collaboratively across R&D and Operations to align and influence a broad range of development strategies that directly support drug development programs.
• Identifies, evaluates, and proposes both internal and external collaborations to drive scientific innovation and shared learning.
• Accountable for compliance with Environmental Health and Safety regulations for the group.

Qualifications

• 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 CMC development organization, such as analytical development, drug substance, parenteral and/or combination products with a range of experience levels and scientific disciplines.
• Skilled in analytical method development, validation, transfer and troubleshooting for biologics. Familiar with extended characterization to evaluate critical quality attributes (CQAs), assess process changes, and prove biosimilarity.
• In depth knowledge in relevant regulations, interactions with regulatory agencies, and deep NDA and BLA experience with major responsibilities.

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