The Vice President, Small Molecule API Development will lead the small molecule and ADC drug substance process development function within the Small Molecule CMC Development organization. Develops and implements effective strategies for small molecule and ADC API process development to support candidate selection, pre-clinical & clinical development, regulatory submissions and initial launch of AbbVie products. Recognized industry leader with expertise in CMC development, regulatory and quality compliance. Adept at developing intellectual property positions. Drives scientific excellence and works across multiple functional areas to deploy capabilities for advancing AbbVie’s pipeline. Leverages capabilities, resources and technical expertise across multiple groups to ensure effective and expeditious decisions. Creates an environment to attract, develop, retain and promote excellent diverse scientific talent. Strong collaborator with a focus on building effective relationships with internal and external partners and stakeholders.
Lead the small molecule and antibody drug conjugate API Development organization, a key function within Small Molecule CMC development with complete accountability for AbbVie’s small molecule and ADC pipeline.
Ensure that the function provides scientific leadership and process development excellence to drive the development and commercialization of safe, high quality, robust and cost-effective small molecule and ADC API processes.
Provide scientific expertise and direction to business strategy and decision-making processes. Make critical scientific decisions to meet changing business needs. Foster collaborations with other functions inside and outside of R&D.
Develop strategies that drive stage appropriate API development, technical excellence, and innovation in science to improve the future capabilities and productivity of the broader organization.
Responsible for talent strategy, including leadership and technical development within the function to generate future scientific talent and leaders. This includes establishing a sustainable high functioning team that seamlessly integrates with the product development CMC core teams and asset strategy teams. Foster and encourage a truly collaborative organization with high morale and consistent with expectations set by AbbVie’s Talent Philosophy.
Collaborate with other functions within AbbVie to align on a broad range of strategies that directly support small molecule and ADC drug discovery and development programs; these include but are not limited to other areas in Development Biological Sciences, Discovery Research, Drug Product Development, Analytical R&D, Combination Product Development, Regulatory Affairs, Quality Assurance and Commercial Manufacturing Operations.
Form particularly strong cross-functional alliances with Discovery Research, CMC Regulatory Affairs and Commercial Manufacturing Operations to ensure high quality candidate selection and development and execution of robust API strategies. Collaborate with Regulatory Affairs, Drug Product Development, Analytical R&D and Commercial Manufacturing Operations to ensure robust and effective control strategies in API process development and commercialization by driving innovation and consistency in API development practices leading to designing APIs best suited to meet the intended drug product profiles.
Responsible for critical path decisions, strategic planning and technology development to meet business and regulatory requirements.
Accountable for small molecule and ADC API commercial process development and technology transfer to commercial manufacturing sites.
Responsible for compliance with applicable Corporate policies and procedures.
- PhD in chemistry, chemical engineering or closely related discipline with 10+ years of experience in pharmaceutical and/or biotechnology industry.
- Senior leadership experience leading large and highly technical organizations.
- Expertise in drug substance and CMC development. Possess and maintain a broad understanding of both scientific and regulatory requirements in the areas of responsibility and overall pharmaceutical R&D, as well as manufacturing and quality.
- Demonstrated ability and dynamic leadership capabilities to function effectively in a cross functional matrixed environment.
- Demonstrated ability to attract and develop key talent, grow the capabilities of an organization and develop future leaders.
- Proven capability to solve critical business and scientific problems.
- Proven experience in budgetary, talent and performance management responsibilities.
- Experience leading in a global environment.
- Recognized CMC leader in the pharmaceutical and biotechnology industry.
- Understanding of cGMP and global regulatory requirements.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.