Director, Analytical Development and Testing
Responsible for all aspects of Analytical Development within the CMC team. This includes overseeing Neurocrine internal programs including VMAT2 Registration, Validation and Commercialization, liaising with CMOs to ensure methods are developed and validated/qualified as per current regulatory requirements, and ensuring API and drug lots are tested and released to meet project timelines and supply clinical needs. Additionally, internal coordination with NBI QA/Regulatory/CMC departments is required to implement API and DP specifications, and to author/review internal SOP’s, and analytical sections of regulatory documentation.Responsible for analytical testing and release of all APIs and drug products in clinical development, including detailed review of COA’s. Supervise and coordinate the development, qualification/validation and transfer of analytical methods at global CMOs to meet project timelines, including detailed review of protocols and final reports, to ensure these activities have met cGMP requirements. Manage, in an effective manner, project-specific interfaces within and outside of the CMC group to ensure successful and timely progression of drug candidates. Develop, along with other CMC team members, drug substance and product specifications. Ensure proper application of regulations and guidelines (GMP & ICH) for the development of methods and specifications. Review and approve analytical methods, validation protocols and reports, and reference standard COA’s. Participate in the review and approval of release testing and stability testing results for raw materials, intermediates, drug substances, and drug products. Actively participate in resolution of technical issues during manufacturing and release of clinical trial material at contract sites.Perform data reviews at contract labs to help define expectations and qualify new or existing contract facilities for analytical testing and regulatory inspections. 10-15% travel may be required to visit CMOs as needed, including performing audits to qualify new facilities. All GMP analytical work is contracted externally.