Associate Director, CMC Development

About Neurocentria Neurocentria is a neuroscience company focused on developing products to promote brain health. Our lead compound, Magnesium L-Threonate (MgT), was developed based on 20 years of research into the regulation of synaptic density and function. MgT has been marketed as a dietary supplement for brain health since 2012, and has been widely adopted by consumers nationwide. We also have an active drug development program evaluating MgT for the treatment of neurological disorders including ADHD, depression, and Alzheimer's disease. In addition to our MgT programs, we are actively searching for new bioactive compounds with properties similar to MgT. One key approach is isolating bioactive components from foods shown to benefit brain health and advancing these extracts toward human clinical trials. This CMC role is central to that effort. The Role We are looking for a Senior Manager, CMC Development to own the chemistry, manufacturing, and controls (CMC) function across our new natural product extract pipeline and nutraceutical product development. You will lead botanical extraction process development, finished product formulation, analytical method development, and contract manufacturer management—taking bioactive extracts from lab-scale through GMP clinical supply. You will also manage the repositioning of our existing controlled-release MgT formulation from drug-grade to nutraceutical-grade manufacturing. Responsibilities Lead extraction process development and scale-up for proprietary botanical extracts, including raw material supplier qualification, process optimization, and pilot-scale manufacturing Develop a combination tablet formulation incorporating multiple active ingredients, from excipient compatibility through prototype testing and optimization Develop and validate analytical methods (HPLC, LC/MS) for bioactive standardization and release testing of natural product extracts Establish raw material and extract specifications, generate Certificates of Analysis, and design and manage stability programs Identify, qualify, and manage relationships with GMP contract manufacturers for clinical supply and commercial readiness Lead technology transfer of formulations to CMOs, including process parameters, analytical methods, and in-process controls Prepare CMC sections of regulatory and IRB submission packages Manage the transition of an existing controlled-release formulation to nutraceutical-grade manufacturing, including CMO selection, technology transfer, and release profile equivalence testing Coordinate with clinical, regulatory, and drug product development teams to ensure product readiness for human clinical trials Manage project timelines, vendor deliverables, and budgets across multiple concurrent CMC workstreams Required Qualifications M.S. or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Natural Products Chemistry, or a related discipline 8-12 years of experience in CMC development, spanning extraction or purification of natural products, formulation, and manufacturing scale-up Proven experience managing CMO relationships from qualification through batch production Hands-on analytical method development and validation experience (HPLC, LC/MS) for botanical or natural product matrices Working knowledge of GMP requirements for dietary supplements (21 CFR Part 111) and familiarity with pharmaceutical GMP (21 CFR Parts 210/211) Experience preparing CMC documentation for regulatory submissions Strong project management skills with the ability to manage multiple vendors and timelines concurrently Preferred Qualifications Direct experience with mushroom or botanical extraction processes Experience with controlled-release tablet formulation and manufacturing Familiarity with ICH stability guidelines and USP monographs for dietary supplements Experience supporting clinical trials from a CMC and clinical supply perspective Background in neuroscience or cognitive health is a plus What We Offer Opportunity to build the CMC function from the ground up at a pioneering neuroscience company Direct ownership of the full product development pipeline—from raw material through clinical-grade finished dosage forms A collaborative, small-team environment at the intersection of natural products science, neurobiology, and clinical development Salary range: $170,000 - $205,000 (depending on experience, qualifications, and location) 401(k) with above-market company contribution Comprehensive medical, dental, vision, and life insurance (100% employee premium coverage; 50% dependent premium coverage) Paid time off including vacation, floating holiday, sick leave, and annual winter week shutdown