Scope & Purpose: The Director of CMC, External Operations will provide strategic leadership for outsourced CMC development, leveraging external partnerships to ensure the timely, high-quality execution of CMC activities that support clinical development and accelerate clinical proof of concept (cPOC). The primary focus of this role is the identification, qualification, selection, management, and oversight of external manufacturing partners in China to ensure the reliable delivery of GMP clinical supplies and regulatory-compliant CMC development activities.

This role will be accountable for developing and executing CMC outsourcing strategies, overseeing external development and manufacturing programs, ensuring technical excellence and quality compliance across outsourced activities, and serving as the primary CMC interface between AbbVie and external partners.

The individual will drive program execution, proactively manage risks, and ensure external CMC activities are aligned with program timelines, quality standards, and regulatory expectations. Additionally, he/she will also provide support to regulatory submissions.

Main Responsibilities:

1. Develop and execute CMC strategies aligned with clinical development timelines and regulatory requirements. Serve as a CMC lead on AbbVie’s project team.
2. Identify, evaluate, select and manage CMO/CDMO partners based on technical capabilities, quality systems, capacity, timelines, and cost considerations. Lead due diligence and technical assessment of potential manufacturing partners.
3. Lead the negotiation of the Manufacturing Service Agreement, ensure that effective planning and materials procurement strategies are in place.
4. Establish effective governance models with external partners, including communication plans, oversight strategies, project milestones, risk management, and performance monitoring.
5. Serve as the primary AbbVie CMC point of contact and ensure successful execution of outsourced activities, including process development, analytical development, formulation development, GMP manufacturing, fill-finish, packaging, and stability studies. Monitor progress, identify potential technical and operational risks and implement mitigation strategies.
6. Review and provide technical oversight of manufacturing processes, batch records, process characterization, and technology transfer activities.
7. Partner with Quality Assurance, Regulatory Affairs to ensure compliance with applicable GMP and regulatory requirements. Ensure timely delivery of clinical trial materials.
8. Provide CMC input into regulatory submissions, including IND/CTA, IMPD, and other global filings.
9. Oversee preparation and review of CMC documentation, including Module 3 sections and supporting technical documents, supporting regulatory interactions related to CMC activities.
10. Collaboration with cross-functional teams including research, nonclinical, clinical operations, regulatory affairs, and clinical drug supply teams to support program advancement. Maintain ongoing communication with the appropriate AbbVie US stakeholders about CMC progress, risks, and recommendations throughout the manufacturing cycle.