Director, Analytical Development

About the role

The Director will be responsible for leading a diverse team supporting AbbVie's pipeline which includes novel NCEs, peptides, and biologic products from natural sources. He/she will lead the groups to drive the development of industry-leading analytical methods, analytical characterization packages and control strategies to advance pipeline programs from clinical development through commercial manufacturing. He/she will partner cross-functionally to drive robust drug substance and drug product manufacturing process development by providing key analytical data and insights. He/she will advance fundamental understanding of drug release and product performance by developing the bioequivalence safe space and/or IVIVC using physiologically based biopharmaceutics modeling through close collaborations with clinical pharmacology and formulation development. He/she will lead physicochemical characterization and establishing the relationship between the compound properties and the product performance in vitro and in vivo.

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 NCEs, peptides and other potential new modalities
• Responsible for development, validation and transfer of analytical methods aligned with the strategies
• Establishes industry-leading analytical capabilities to support process development, formulation, technology transfer and post-approval changes
• Drives fundamental understanding of drug release and product performance and develop biopharmaceutics risk assessment based biowaiver strategies
• 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
• 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
• Familiar with commercial manufacturing and testing and able to be a partner in strategic initiatives in the commercial space for modernization of manufacturing and controls
• Manages and develops scientific talent (20-30 Scientist, Senior Scientists, and Managers) across multiple disciplines and/or projects to address current and future business needs.
• 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
• 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 masters degree with at least 15 years of pharma/biotech experience.
• Proven experience leading a CMC development organization with a range of experience levels and scientific disciplines.
• Skilled in physical characterization, structural elucidation and establishing relationship between compound/formulation properties and performance
• In depth knowledge in relevant regulations, interactions with regulatory agencies, and NDA and/or BLA experience with major responsibilities.
• Extensive experience and solid understanding of the various scientific disciplines, including analytical control strategies, dissolution, biopharmaceutics, formulation development, regulatory filings, manufacturing, QA, and supply chain.
• Demonstrated record of success leading strategic initiatives and new technology evaluation/implementation.
• Track record on people management experience and leading matrix teams.
• 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.
• Strong negotiating, influencing, and leadership skills.