Director, Pharmaceutical Development

Role Summary

Director level role leading a global analytical development organization supporting AbbVie's pipeline, including novel NCEs, peptides, and biologics. The role drives development of analytical methods, characterization packages, and control strategies from clinical development through commercial manufacturing. It partners cross-functionally to advance drug substance and drug product manufacturing processes and provides key analytical data and insights. It advances understanding of drug release and product performance through biopharmaceutics modeling, IVIVC, and physicochemical characterization in collaboration with clinical pharmacology and formulation development.

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 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 master’s 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.