Director, CMC Product Development

Job Description

Job Description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Advance your career as Director, CMC Product Development , 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

Qualifications

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law : ​

Note : No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico only - to learn more, visit  https : / / www.abbvie.com / join -us / equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

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