Linda Dow Email and Phone Number

Developed CMC regulatory strategies for small molecule and biologic combination products: pre-approval, post-approval, NDAs, BLAs, INDs, IMPDs. Led cross-functional teams to develop submission content and successfully address global regulatory information requests. Established collaborative team environment with internal and external partners to deliver timely technical content.

Created an organization to focus expertise on the development and execution of process-related support activities to enable delivery of the small molecule portfolio. Key areas: collaboration partner relationships including capability and capacity assessments, internal compliance, strategic planning, forecasting, resourcing, communications and general lab operations.

Delivered the small molecule portfolio via leadership of analytical chemists supporting API. Built a robust external network of service providers and established efficient analytical workflows, empowering individuals to help drive change. Continued to shape external and internal approaches for the control of genotoxic impurities.

Provided analytical technical leadership for early, mid and late phase portfolio projects. Established phase appropriate analytical control strategies for API in collaboration with process chemists and engineers. Developed and implemented GTI strategies to ensure safety of the patient and compliance with regulatory guidelines.

Successfully implemented projects focused on highly cross-functional and cross-component processes within a research and development environment. These projects brought greater efficiency to the organization and fostered communication and shared learnings across diverse cultures. Projects spanned the drug development timeline from discovery to commercialization.

Key scientific contributor to the study of intra- and inter-molecular interactions. Expert in small and large molecule NMR and application of Diffusion Ordered Spectroscopy (DOSY). Collaborated with customers in discovery and manufacturing to characterize biophysical properties, conduct mechanistic studies, complete structural identifications and understand compound interactions.

Characterization of biomolecules via multiple HPLC and GC methods. Established regulatory readiness for domestic and international laboratories. Conducted validation and statistical analysis of HPLC methods for inter-laboratory transfer. Supervision and direction of laboratory technicians.