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VitaKey Inc. · 5 days ago

Senior Scientist, Formulation and Process Development

Triangle Area

Full-time

Onsite

Mid, Senior Level

4+ years exp

VitaKey Inc. is an exciting start-up developing proprietary technology for health improvement through food and beverages. The Senior Scientist will lead formulation and process development, conduct hands-on laboratory work, and manage interactions with manufacturing partners while contributing to interdisciplinary projects.

Food and BeverageMedical

Responsibilities

Hands-on, benchwork-first role, reporting to project leader(s)

Use 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

Qualification

Formulation developmentProcess developmentMicrobial stabilizationQbD scale-upSpray dryingHot melt extrusionFluidized bed coatingWet granulationDry granulationLyophilizationCross-disciplinary communicationEntrepreneurial mindsetStartup experienceTeam player

Required

MS with a minimum of 4-7 years of experience or PhD with 2-4 years of experience in food technology, probiotic technology, nutraceutical technology, and/or cosmetic industries in process development and/or manufacturing

Enthusiasm for benchwork and a team player

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

Candidates must work full time on-site in Durham, NC

Ability to adjust rapidly to changing scientific priorities and technologies

Preferred

Direct experience formulating and stabilizing microbes is highly preferred

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 consumer goods product with an advanced drug delivery technology are also encouraged to apply

Startup experience is highly valued, but not required