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Chief Scientific Officer at VitaKey Inc.

VitaKey is an exciting start-up using proprietary technology for encapsulating macronutrients, micronutrients, probiotics, biologics, small molecules, etc. to improve the nutritional value of 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 building, leading, designing, and executing on process development and manufacturing for VitaKey platform technologies. Responsibilities will also include hands-on benchwork in an R&D laboratory, travel to partner manufacturing sites (~20% 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 with the opportunity to build a process development/manufacturing team. Projects will be highly interdisciplinary, at the intersection of engineering, biochemistry, materials science, food science, and nutrition.

Duties and Responsibilities

1. Identify, evaluate, select, and manage process development and manufacturing partners including coordinating material and data transfer.
2. Use spray drying, hot melt extrusion, fluidized bed coating, wet granulation, dry granulation, various milling, lyophilization, etc. for hands-on preparation of VitaKey formulations at lab scale.
3. Use the principles of spray drying, hot melt extrusion, fluidized bed coating, wet granulation, dry granulation, various milling, lyophilization, etc. to enable QBD large-scale manufacturing (e.g., single, double, triple-digit kg) of VitaKey formulations at selected process development and manufacturing partners.
4. 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.
5. Establish documentation practices including sample submission systems, method validations, certificates of analysis, and method transfers.
6. Establish batch testing specifications for raw materials and formulations manufactured at scale to support lot release.
7. Interface with bench formulation R&D teams, analytical development, and clinical teams to support company-wide objectives; regularly present findings at company meetings.
8. Define and execute long term vision for process development to ensure technology transfer from lab-scale to pilot-/manufacturing-scales.
9. Work with external partners for raw materials selection and characterization.
10. Travel to pilot-/manufacturing-sites to oversee and lead process development.
11. May mentor and direct other scientists.

Qualifications

1. MS with a minimum of 5-10 years of experience or PhD with 3-7 years of experience in the pharmaceutical, food, nutraceutical, and/or cosmetics industries in process development and/or manufacturing.
2. Direct experience leading QBD manufacturing scale-up for a marketed product is highly preferred.
3. Candidate must be proficient 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.
4. Experience working with professionals from formulation science, chemical engineering, bioengineering, pharmaceutical sciences, polymer chemistry, food science or allied disciplines.
5. Experience with QA, QC, CQA, establishing testing specifications, determining critical process parameters, etc.
6. Experience working with proteins, carbohydrates, polymers, microparticles, bacteria, and/or lipids.
7. Entrepreneurial and self-motivated work style; comfort in ambiguity.
8. Excellent cross-disciplinary skills in communicating ideas to both scientists and non-scientists.
9. Startup experience is highly valued, but not required.
10. Ability to adjust rapidly to changing scientific priorities and technologies.

Seniority level

Not Applicable

Employment type

Full-time

Job function

Management and Manufacturing

Industries

Biotechnology