Leads the Global New Chemical Entity Drug Product Development (NCE DPD) function with AbbVie R&D Development Sciences. Develops and implements effective strategies for global NCE formulation and drug product development to support CMC activities required for clinical development, regulatory submissions, approval and initial launch of AbbVie products. Is in an industry leadership position relative to scientific excellence, expertise in CMC development, regulatory and quality compliance, and the establishment of intellectual property positions. Work across multiple functional areas to assure availability of capabilities for advancing AbbVie’s pipeline. Balance capability and capacity of technical expertise across multiple sites assuring effective decision making in a timely and expeditious manner. Creates an environment that attracts, develops, retains and promotes excellent diverse scientific talents, communicating clearly and concisely and building effective relationships with internal and external partners and customers.
- Lead NCE Drug Product Development, a major function within R&D CMC with complete accountability for the AbbVie R&D’s small molecule pipeline
- Ensure that function provides scientific leadership and formulation and drug product development excellence to drive the development and commercialization of patient centric, robust and cost-effective NCE drug product processes and products
- Assures scientific expertise/direction is provided into business strategy and decision making processes. Makes difficult scientific decisions to meet changing business needs. Fosters collaborations with other functions inside and outside R&D including cross-functional collaborations.
- Ensure development of strategies that drive formulation and drug product development technical excellence and innovations in science that improve the future capabilities and productivity of the greater organization
- Responsible for talent strategy and leadership and technical development within the function generating future leadership. This includes establishing a sustainable high functioning team that seamlessly integrated with the PPDST teams and ASTs. Fosters and encourages an organization with high morale and consistent with those set by AbbVie’s Talent Philosophy.
- Collaborate with other functions within AbbVie to align a broad range of strategies that directly support small molecule drug discovery and development programs; these include but are not limited to other areas in Development Sciences, NCE Drug Substance Development, NCE Analytical R&D, Combination Product Development, Commercial Operations, Regulatory Affairs, Development, Quality Assurance and Commercial Manufacturing Operations
- Form particularly strong cross-functional alliances with Commercial Operations and Commercial Manufacturing Operations to ensure patient focused drug product presentations. Collaborate with NCE Drug Substance Development, NCE Analytical R&D and Commercial Manufacturing Operations to ensure robust and effective control strategies in development and commercialization by driving consistency in formulation and drug product development practices
- Responsible for critical path decisions, strategic planning and technology development to meet business and regulatory requirements
- Accountable for NCE drug product development and transfer to commercial plants
- Responsible for compliance with applicable Corporate policies and procedures.
- PhD in chemistry, biology, analytical chemistry, chemical engineering or closely related fields with 10+ years of experience in pharmaceutical and/or biotechnology areas
- Senior leadership experience leading large and highly technical organizations
- Extensive experience in drug product development and experience in either or both small molecule and large molecule 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 operate highly effectively in a cross functional matrixed environment
- Demonstrated ability to attract and develop key talents and grow capabilities of an organization and develop people into future leaders
- Proven capability to solve critical business and scientific problems
- Proved experience in budgetary and talent and performance management responsibilities.
- Experience in leading in a global environmentand ideally has international experience.
- Recognized leader in pharmaceutical and biotechnology industry in the CMC aspects
- Understanding of cGMP and global regulatory requirements
Significant Work Activities: N/A
Travel: Yes, 50 % of the Time
Job Type: Experienced