Associate Director, CMC Natural Products Development

Job Description

Job Description

Salary: $170,000-205,000 per year

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 Alzheimers 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 an Associate Director, CMC Natural Products Development to own the chemistry, manufacturing, and controls (CMC) function for our natural product extract pipeline and nutraceutical product development. You will leadbotanical extraction process development, including solvent-based extraction from raw fungal or plant biomass, analytical method development (HPLC, LC/MS) for complex botanical matrices, and formulation of combination tablets, 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 solvent selection, process optimization, raw material supplier qualification, and pilot-scale manufacturing
• Develop and validate analytical methods (HPLC, LC/MS) for bioactive standardization, release testing, and characterization of natural product extracts in complex botanical matrices
• Establish raw material and extract specifications, generate Certificates of Analysis, and design and manage stability programs
• Develop a combination tablet formulation incorporating multiple active ingredients, from excipient compatibility through prototype testing and optimization
• Identify, qualify, and manage relationships with GMP contract manufacturers, including tech transfer, process parameters, analytical methods, release profile equivalence testing, and in-process controls
• Prepare CMC sections of IRB submission packages
• Coordinate with clinical, regulatory, and drug product development teams to ensure product readiness for human clinical trials
• Own project timelines, vendor deliverables, and budgets across CMC workstreams

Required Qualifications

• M.S. or Ph.D. in Natural Products Chemistry, Pharmacognosy, Pharmaceutical Sciences, Chemistry, or a related discipline
• 812 years of experience in CMC or process development, with hands-on experience developing extraction processes for botanical or natural product source materials (solvent selection, process optimization, yield improvement from raw plant or fungal biomass)
• Analytical method development and validation (HPLC, LC/MS) for botanical or natural product matrices
• Working knowledge of GMP requirements for dietary supplements (21 CFR Part 111) or pharmaceutical GMP (21 CFR Parts 210/211)
• Strong project management skills with the ability to manage external partners and timelines concurrently

Preferred Qualifications

• Direct experience with botanical extraction processes at pilot or commercial scale
• Experience managing CMO/CDMO relationships, including tech transfer and GMP batch production
• Tablet or solid oral dosage form development experience, including controlled-release formulations
• Experience preparing CMC documentation for regulatory submissions (IND, IRB, or equivalent)
• 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

• Lead the botanical extraction and natural product characterization workstream within an established CMC program at a pharmaceutical development company advancing novel therapies toward clinical trials
• 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