Therapeutic Oligonucleotide Platform Biologics Chemistry, Manufacturing and Controls (CMC) Subject Matter Expert Consultant   2

Background
The National Institute of Neurological Disorders and Stroke (NINDS) is seeking to support translational development of novel therapeutics, including biologics, that can provide health benefits to patients. The NINDS has established the URGenT program to support the development and clinical evaluation of therapeutics to address ultra-rare genetically based neurological disorders. The NIH Blueprint Neurotherapeutics (BPN) network is a consortium comprised of the NIH Office of the Director and 14 NIH Institutes and Centers (ICs) that support neuroscience research. The program will provide neuroscience researchers with funding and access to a full range of industry-style biologics development services and expertise.

Work Details
The NINDS anticipates needing 1-3 consultants to cover all projects. These individuals would be expected to provide guidance and advice on biologics development processes for the NINDS Ultra-Rare Gene Therapy (URGenT) program, the NIH Blueprint Neurotherapeutics (BPN) Biologics program, and other NINDS and trans-NIH programs where therapeutic oligonucleotide CMC expertise is required. Interested organizations must demonstrate extensive experience with and the ability to perform tasks related to biologics development processes. Documentation may include contracts both Government and commercial, references, i.e., names, titles, telephone numbers, awards, commendations, etc.