Director S&T API
AbbVie
Director of Operations Product Development for Science & Technology APIs at AbbVie, responsible for strategic oversight of API and dosage form development, process scale-up, and technology transfer from R&D to manufacturing operations. The role requires managing cross-functional teams and serving as technical liaison between development and manufacturing organizations.
Responsibilities
- Manage strategies, planning, and risk management for API and dosage form development and process improvements
- Direct cross-functional teams of scientists and technicians to ensure CMC lifecycle activities meet regulatory and quality standards
- Evaluate and implement new manufacturing technologies while maintaining regulatory compliance
- Provide technical leadership for process and regulatory issues; represent AbbVie to regulatory agencies
- Develop business cases and timelines for new opportunities; make go/no-go project decisions
Requirements
- Master's degree or equivalent in a related scientific field
- PhD or equivalent experience in a related scientific discipline highly desired
- 10+ years of experience in API development, manufacturing, formulation, or analytical chemistry
- 6+ years of managerial experience in the pharmaceutical industry
- Strong background in drug development, marketed product support, and technical issue resolution
- Expertise in manufacturing, regulatory, and compliance fields
Vacancy posted 7 days ago
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