Senior Director, CMC, Analytical Stewardship, and Stats Excellence

Job Summary

As Senior Director, Complex CMC Program Leadership, AI/Digital Transformation & Statistical Excellence, you will lead complex global CMC programs from late-stage development through commercialization and lifecycle management. You will integrate technical strategy, regulatory readiness, analytical excellence and digital innovation across Global Technical Operations (GTO) and partner functions.

What You'll Do

Complex CMC Program Leadership | 60%

• Lead global CMC teams for sophisticated biologics programs, including monoclonal antibodies, antibody-drug conjugates, recombinant proteins and emerging modalities.
• Develop CMC strategies across late-stage development, validation, PPQ, regulatory filing, commercialization, launch, technology transfer and ongoing product management.
• Align cross-functional teams and external partners on technical priorities, resources, risks and key decisions to support effective program execution.
• Provide strategic direction for product quality, supply, post-approval changes, manufacturing network changes, complex investigations and inspection readiness.
• Lead CMC content and technical responses for global regulatory submissions and health authority interactions.

AI, Digital & Automation | 20%

• Develop a GTO digital roadmap supporting CMC delivery, analytical stewardship, knowledge transition, and ongoing lifecycle coordination.
• Advance responsible use of generative AI and analytics for technical authoring, information synthesis, risk identification and decision support.
• Identify automation and data opportunities that simplify workflows, improve traceability and support predictive monitoring.
• Establish governance and adoption plans for AI and digital solutions, including data quality, validation, compliance, human oversight and value measurement.

Analytical Stewardship & Statistical Excellence | 20%

• Provide strategic oversight of analytical method lifecycle management, validation, verification, transfer, comparability and method replacement.
• Guide analytical methods to commercial readiness and prepare the network to support diverse products and analytical technologies.
• Apply numerical and analytical expertise to build study design, sampling, comparability, method transfer, acceptance criteria, uncertainty assessment, multivariate analysis and product quality monitoring.
• Advance statistical analysis, predictive analytics and process monitoring to support control strategies and lifecycle decisions.

Leadership

• Build and lead an inclusive global organization with strong CMC, analytical, statistical and digital capabilities.
• Coach leaders and experts while supporting capability development, succession and knowledge continuity.
• Develop collaboration and accountability while aligning resources and priorities with business needs.

Essential Qualifications

• Advanced degree (PhD, MS) in Statistics, Biostatistics, Biochemistry, Analytical Chemistry, Biotechnology, Chemical Engineering, Pharmaceutical Sciences, Data Science or a related field.
• 15+ years of experience in biologics CMC development, commercialization, technical operations, MSAT, analytical sciences, technology transfer or product stewardship.
• Experience leading intricate global CMC initiatives through pivotal development, validation, filing, launch and lifecycle changes.
• Strong knowledge of global regulatory expectations and ICH mentorship for biologics CMC, analytical methods, validation, product handover, and ongoing management throughout the product life.
• Expertise applying statistical and quantitative methods to pharmaceutical development, manufacturing or analytical data.
• Strong critical thinking, communication and executive influence skills.

Preferred Qualifications

• Experience applying AI, digital technologies, automation, advanced analytics or data products in a regulated pharmaceutical environment.