Provide technical expertise for route selection, optimization and scale-up of chemical
processes for the Company's clinical candidates.
Work within a matrix environment to establish and execute the timelines to achieve clinical
Manage the appropriate resources (CMOs, outside vendors, consultants) for the development and
characterization of the active ingredient.
Take initiative to resolve API and, where applicable, broader CMC issues
Represent the CMC function on project teams and resolve cross-functional issues.
Assure the timely preparation, review, and approval of technical reports, monographs, and
portions of CMC sections of regulatory submissions.
Work with quality assurance and regulatory affairs to meet regulatory agency requirements