Drive the execution of CMC documentation strategy for regulatory submissions. Collaborate with experts to prepare high-quality content for biologics products, ensuring alignment with regulatory standards and timely resolution of technical gaps.
Shape the future of biologic product development by leading CMC documentation strategy and execution, ensuring regulatory compliance and scientific rigor across submissions. Collaborate with cross-functional teams to drive timelines and decision-making.
Oversee the CMC strategy for small molecules, ensuring successful development, manufacturing, and compliance with regulatory standards while collaborating across various teams and external partners.
Champion the development and execution of CMC strategies for small molecules, ensuring timely and budget-compliant manufacturing through collaboration across multiple departments and with external partners.
Lead the strategy and execution of commercial drug product manufacturing, ensuring operational performance and supply security while collaborating across teams to develop effective manufacturing plans and mitigate risks.