Technical leadership for cross-functional teams during drug development, commercial launch, or troubleshooting of established processes and sites
Lead and represent the Drug Product (DP) team for a product in late-stage development and/or a commercial product
Lead site transfers to commercial DP manufacturing sites and oversee process validation activities (demo/PPQ)
Represent manufacturing, CCS, and formulation considerations within the PDS&T CMC team
Develop, manage and implement global initiatives to improve CMC drug development and commercial support strategies
Prepare project-specific documents, e.g., QTPP, formulation declaration, control strategy documentation
Review and approve GMP-compliant and regulatory documents (such as IMPD, IND, CTD for clinical trials and BLA, NDA, PAS for marketing authorization applications)
Actively communicate project strategies, key issues and risks to the PDS&T CMC team, functional leadership and SMEs, and present complex technical topics to the development team and management

Pharmacist, chemist, biochemist, biologist or equivalent, preferably with a PhD
8+ years' experience in relevant areas of parenteral product development and/or commercial support
Proven track record advancing complex parenteral drug programs through late-stage development with recognized technical depth and scientific leadership
Strong experience leading technology transfer from R&D to operations is highly desirable
Extensive experience in product development and commercial support in late development stages is preferred
Deep understanding of parenteral drug development, including formulation, process development, manufacturability and lifecycle considerations
Ability to lead multiple concurrent priorities in a dynamic, collaborative environment; strong expertise in global CMC drug development, strategic planning and project execution
Experience supporting preparation of clinical and regulatory dossiers as well as marketing authorization applications, including IMPD, IND, CTD, BLA, NDA and PAS
Experience in a cGMP-regulated environment with solid knowledge of relevant international regulatory and quality requirements, particularly those in the US and EU
Strong leadership skills with demonstrated ability to influence and collaborate effectively in direct and cross-functional teams within a matrix organization

Drug Product Lead

Key skills