Director of Research and Development

Director of Research and Development The Director of Quality & R&D oversees all Quality Assurance (QA), Quality Control (QC), Product Development, and Research & Development (R&D) activities for the company’s RTD pharmaceutical product portfolio. This role provides both strategic leadership and hands-on technical direction to a small but high-impact team responsible for ensuring product safety, regulatory compliance, scientific innovation, and continuous improvement. The ideal candidate brings deep experience in FDA-regulated manufacturing environments, strong understanding of peptide formulation science, and proven success in building and scaling quality systems in a fast-growing operation. This leader will drive quality excellence, guide the development of RTD formulations, and ensure all products meet or exceed regulatory, safety, and efficacy standards . This is a Direct Hire position with a salary between $175K to $220K yearly base salary plus benefits plus bonus of 15-25% . The total cash component of salary is estimated to be between $220K to $280K. This position is based in Charleston SC Key Responsibilities Quality Leadership & Compliance Oversee all Quality Assurance and Quality Control activities, ensuring full compliance with FDA, cGMP, and relevant pharmaceutical quality regulations. Maintain and continuously improve quality systems, including SOPs, batch record review, documentation control, deviation investigations, CAPA, and change control. Lead internal and external audits, manage responses, and ensure inspection readiness at all times. Ensure compliance with product testing standards, stability studies, raw material qualification, and finished product release protocols. R&D & Product Development Lead the innovation pipeline for RTD pharmaceutical formulations, focusing on safety, stability, efficacy, and manufacturability. Oversee formulation development, benchtop trials, scale-up testing, and transfer to manufacturing. Collaborate with Operations to optimize production processes, reduce variability, and enhance product quality. Maintain strong scientific rigor across experimental design, documentation, validation, and analytical methodology. Leadership & Team Management Manage and develop a team of QA and R&D professionals. Create a culture of scientific excellence, accountability, and continuous improvement. Collaborate cross-functionally with Operations, Supply Chain, Regulatory, and Executive Leadership. Regulatory & Documentation Ensure compliance with 21 CFR Part 210/211 and all applicable federal and state pharmaceutical regulations. Maintain robust documentation systems that ensure data integrity, traceability, and regulatory alignment. Support regulatory submissions, labeling requirements, and product technical dossiers. Continuous Improvement & Technical Operations Implement quality and efficiency improvements using root cause analysis, risk assessment, and quality engineering tools. Identify and mitigate quality risks across manufacturing and development. Monitor quality metrics, trend analysis, and key performance indicators to guide quality strategy. Education Bachelor’s degree in chemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline. Master’s degree or higher is preferred. Experience 7–10+ years of experience in FDA-regulated pharmaceutical, nutraceutical, or related manufacturing environments. Experience in peptide formulation is strongly preferred. Knowledge in sterile injectables and lyophilization highly preferred. Demonstrated leadership experience managing QA/QC and/or R&D teams. Proven success developing and implementing compliant quality systems. Skills & Competencies Deep knowledge of FDA regulations, cGMP, quality systems, and product development processes. Strong formulation science background, especially with liquids, suspensions, emulsions. Excellent analytical, problem-solving, and project management skills. Ability to lead both strategically and hands-on in a fast-paced growth environment. Strong communication, technical writing, and cross-functional leadership capability. Preferred Qualifications Prior experience with scale-up, tech transfer, and manufacturing optimization. Familiarity with stability programs, analytical testing, and validation protocols. Lean Six Sigma or similar process improvement training Key Words: pharmaceutical, nutraceutical R & D Research and development sterile injectables lyophilization FDA Quality Control Medical Pharmacy Six Sigma Bachelor’s Degree Requirement: Yes Bachelor's degree required. 7 to 10 years of experience required.