Director of Research and Development
PCR Staffing
Charleston, SC
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.