Sr. Director of CMC management

Company Description WuXi XDC is a leading CRDMO specializing in antibody-drug conjugates (ADCs) and broader bioconjugates, offering integrated services from early concept development through commercialization. The company operates state-of-the-art laboratories and manufacturing facilities located in close proximity, enabling efficient workflows, shortened development timelines, and reduced costs. With a global network of over 3,000 skilled employees, WuXi XDC provides an open-access platform with comprehensive capabilities and advanced technologies. By partnering with biopharmaceutical companies worldwide, WuXi XDC helps accelerate innovation and transform bioconjugate development to improve outcomes for patients across the globe.

Role Description The Sr. Director of CMC Management is a full-time, remote role responsible for overseeing Chemistry, Manufacturing, and Controls (CMC) strategy and execution for ADC and bioconjugate programs. This position leads cross-functional CMC planning, including process development, analytical strategy, technology transfer, and manufacturing readiness across drug substance, linker, payload, and drug product. The Sr. Director guides the preparation and review of CMC documentation for regulatory submissions, ensures compliance with global regulatory and quality standards, and manages risk and issue resolution throughout the product lifecycle. Day-to-day activities include directing internal and external project teams, aligning CMC activities with program timelines and budgets, and communicating progress, risks, and mitigations to senior leadership and partners. The role also contributes to continuous improvement of CMC frameworks, governance, and technical capabilities to support WuXi XDC’s growing portfolio.

Qualifications

• Strong expertise in CMC management, including process development, analytical development, scale-up, and technology transfer for biologics, ADCs, or bioconjugates.
• Demonstrated experience with regulatory CMC requirements (e.g., IND/IMPD/BLA/MAA content), quality systems, and global GMP standards.
• Proven leadership skills in managing cross-functional teams, external partners, and complex multi-site projects in a remote or global environment.
• Advanced understanding of biopharmaceutical manufacturing operations, supply chain coordination, and lifecycle management for clinical and commercial products.
• Excellent communication, stakeholder management, and decision-making skills, with the ability to translate technical topics into clear strategic recommendations.
• > 15 years of Biologics CMC related experience in Biotech or Pharma.
• PhD in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related field, with substantial industry experience in CMC for biologics or ADCs.
• Experience in a CDMO/CRDMO is plus.
• Fluent in Manarian.