Senior Scientist, Formulation and Process Development

VitaKey is an exciting start-up developing and commercializing proprietary technology for controlled, targeted, extended, and sustained delivery of macronutrients, micronutrients, probiotics, biologics, small molecules, etc. to be included in everyday foods and beverages to improve human health. We are seeking innovative and motivated scientists and engineers to be part of the company's next-phase of growth at our Durham NC HQ. Learn more about our company on our website at www.VitaKey.com

Role Summary

Responsibilities will involve leading, designing, and executing on formulation and process development for VitaKey platform technologies, including technologies for microbial formulations. Responsibilities will also include hands-on benchwork in an R&D laboratory preparing formulations for microbes, travel to partner manufacturing sites (~15% travel), technology transfer from lab scale to pilot and manufacturing scale. Responsibilities will also include identifying, selecting, and managing interactions with process development and manufacturing partners. You will serve as an independent contributor. Projects will be highly interdisciplinary, at the intersection of engineering, biochemistry, materials science, food science and nutrition.

Duties and Responsibilities

• Use the principles of spray drying, hot melt extrusion, fluidized bed coating, wet granulation, dry granulation, various milling, lyophilization, etc. to formulate microbes and nutrient payloads at lab scale
• Design and manufacture formulations with drug delivery technologies including nutrient stabilization, extended release, and targeted delivery
• Identify, evaluate, select, and manage process development and manufacturing partners including coordinating material and data transfer
• Execute QbD scale-up of lab scale formulations to large-scale manufacturing (e.g., single, double, triple-digit kg) at selected partners
• Identify critical quality attributes and process parameters and implement appropriate analytical methodology (e.g., FT-IR, Raman, viscosity, MS/MS, particle size analysis, microscopy, differential scanning calorimetry, UV-VIS, water activity) to support technology transfer from lab scale to pilot and manufacturing scale
• Establish documentation practices including sample submission systems, method validations, certificates of analysis, and method transfers
• Prepare monthly reports of project progress
• Interface with bench formulation R&D teams, analytical development, and clinical teams to support company-wide objectives; regularly present findings at company meetings
• Work with external partners for raw materials selection and characterization
• Travel to pilot-/manufacturing-sites to oversee and lead process development
• May mentor and direct other scientists

Qualifications

• MS with a minimum of 4-7 years of experience or PhD with 2-4 years of experience in food technology, probiotic technology, pharmaceutical delivery sciences, nutraceutical technology, and/or cosmetic formulations industries in process development and/or manufacturing
• Direct experience formulating and stabilizing microbes
• Direct experience leading QbD scale up of a delivery technology from bench to multi-kg scale for a marketed product within the food technology or probiotic spaces is highly preferred; candidates who have developed a marketed product with an advanced drug delivery technology are also encouraged to apply
• Candidate must be an expert in at least 2 of the following unit operations: spray drying, hot melt extrusion, fluidized bed coating, wet granulation, dry granulation, various milling, and lyophilization
• Experience working with professionals from formulation science, chemical engineering, bioengineering, pharmaceutical sciences, polymer chemistry, food science or allied disciplines
• Experience with QA, QC, CQA, establishing testing specifications, determining critical process parameters, etc.
• Entrepreneurial and self-motivated work style; comfort in ambiguity
• Excellent cross-disciplinary skills in communicating ideas to both scientists and non-scientists
• Startup experience is highly valued, but not required.
• Candidates must work full time on-site in Durham, NC
• Ability to adjust rapidly to changing scientific priorities and technologies