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Director, cmc product development (all genders) (full-time, permanent)

Bodman-Ludwigshafen
Festanstellung
AbbVie
Director
Inserat online seit: 30 September
Beschreibung

Job Description Advance your career as Director, CMC Product Development (all genders), where you’ll oversee the CMC aspects of drug and combination product development across programs, align strategy with clinical and regulatory goals, and lead a global, cross-functional team. Collaborate with key partners, communicate critical updates to senior management, and drive robust CMC plans in support of global filings and approvals. Ideal candidates bring deep CMC drug development and team leadership experience, strategic vision, and a strong record in supporting clinical and regulatory milestones. Join us to shape the future of global drug development. Responsibilities Serves as spokesperson for CMC on the Asset Development Team, promoting effective information flow and collaboration across all line functions Ensures excellence in science, technology, and deliverables while maintaining compliance with global regulatory and quality standards, including active participation in meetings with authorities and pre-approval inspections Critically evaluates and integrates drug substance, product, and device inputs into CMC strategies aligned with business and compliance objectives Utilizes a matrix management approach to oversee a limited project portfolio, negotiating resources and fostering efficiency in timelines, budgets, and team development Leads contract reviews with third-party partners, manage project budgets with ADT collaboration, and ensure successful CMC execution and quality deliverables within approved funding Guides CMC development teams by organizing meetings, setting agendas, highlighting achievements and risks, and conducting reviews to efficiently meet phase transition criteria Advances corporate and divisional initiatives, encourage creative and scientific thinking, and champion quality and resource management. Develops, updates, and implements CMC product development plans while ensuring regulatory, health, safety, and environmental compliance, and support high-quality global filings, approvals, and product launches

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