Principal Investigator, Analytical Development
The individual will independently support the NDA filing activities of Chemical Development related principally to the Neurocrine VMAT-2 program. The successful candidate will write CMC analytical sections of regulatory filing documents in CTD format based on data provided by collaborating CMOs. The individual will apply national and international guidance documentation in justification of analytical limits, acceptance criteria, testing parameters and method validation and execution. The individual is expected to effectively document research and to conduct work in a safe manner in accordance with company and departmental guidelines.
The successful candidate will have a Ph.D. in chemistry with at least five years, or an MS with 8-10 years, or a BS with 12 + years’ experience in late stage analytical pharmaceutical/process development. In addition to analytical development expertise, candidates will have demonstrated experience with FDA filings. A minimal requirement is experience writing CMC/Analytical sections of an NDA or CMC/Analytical sections of multiple INDs. Good understanding of cGMP requirements for API manufacturing.