CHEMISTRY MANUFACTURING CONTROL [CMC] / PHARMACEUTICS / FORMULATION CONSULTANT SUPPORT SERVICES

点击翻译按钮获取中文摘要

The Contractor provides support services to the NIH Blueprint Neurotherapeutics Network for chemistry manufacturing control (CMC) / Pharmaceutics / Formulation CMC / Pharmaceutics / Formulation consultants provide senior-level CMC / Pharmaceutics / Formulation expertise and contribute feedback and guidance on projects to the National Institutes of Health (NIH) and to lead development team (LDT) members through conference calls and by email. The role of the CMC / Pharmaceutics / Formulation consultant may include but is not limited to the following responsibilities and tasks: • Evaluate CMC activities for Blueprint Neurotherapeutics (BPN) compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines. • Identify and assess regulatory risks for compounds under development and provide CMC guidance to BPN and LDTs. Develop CMC strategies which accord with US and international guidelines. • Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules. • Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules. • Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including the Food and Drug Administration (FDA), European Medicines Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications. • Provide expertise in activities related to active pharmaceutical ingredient (API) development. • Recommend dose form selection and API development strategies for BPN efforts. • Develop plans to assist NIH BPN staff in strategically managing chemical manufacturing and controls pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies. • Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations [CRO] under contract with BPN. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff. • Assist NIH BPN staff to design investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed. • Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.