Join to apply for the Executive Director, CMC role at WuXi Biologics We are seeking an experienced Executive Director to lead our CMC team. The ideal candidate will have a strong background in bioprocess development and manufacturing, as well as experience in team management and new site establishment. Responsibilities: Provide project leadership supporting process development, GMP manufacturing, and related CMC activities at the US site. Participate in establishing WuXi Biologics CMC strategies and recommendations to support ongoing projects in different stages of CMC development. Lead MVP CMC projects with a good understanding of potential technical challenges and meet regulatory requirements and ICH’s quality and efficacy guidelines. Collaborate with CMC functional areas to ensure successful execution of various CMC projects and delivery of results on time and within budget. Chart the course, track progress against goals, and outline key strategic events for the project. Manage project scope definitions and changes, and budgets. Serve as the center of solution, addressing any challenges and issues that arise, and make hard decisions. Engage efficiently with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements, and timelines. Build solid communication with clients to ensure alignment between WuXi Biologics and clients. Provide leadership in development and manufacturing alliance management, product development, and manufacturing strategy. Support BD efforts and proposal writing teams to enhance current service offerings and develop new clients in RTP and other Mid-Atlantic territory as appropriate. Qualifications: Ph.D. in chemical engineering, biochemical science, or a related discipline with at least 15 years of bioprocess development and manufacturing experience in the biopharmaceutical industry. More than 10 years of managerial experience in team development and new site establishment. At least 4 years of experience managing multiple sites in a CRDMO company. Knowledge of cGMP and regulatory requirements in the pharmaceutical industry and a detailed understanding of the principles and concepts related to biologics drug development. Strong awareness of global teamwork with an optimistic work attitude. Willingness to travel as required internationally to fulfill the responsibilities of the position. Demonstrated capability and enthusiasm to establish high-performance teams. Excellent communication skills to engage with personnel from multiple disciplines and experience bases across the operations organization. Strong skills in reviewing technical results, troubleshooting, investigations, and drug life cycle CMC management. Experience in supporting internal/external audits and regulatory inspections. The anticipated pay range for this position is $175,000-$275,000.

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