Job Summary
We are seeking an experienced Licensed Pharmacist with extensive expertise in pharmaceutical compounding to lead the establishment and operation of a compliant compounding laboratory. The ideal candidate will have 8–10+ years of experience in pharmaceutical or pharmacy practice, with hands-on involvement in setting up compounding facilities, developing quality systems, and ensuring regulatory compliance.
Key Responsibilities
- Lead the planning, setup, and operation of pharmaceutical compounding laboratories.
- Ensure compliance with USP <795>, USP <797>, and USP <800> standards.
- Prepare and manage FDA License to Operate (LTO) applications and other regulatory submissions.
- Develop, review, and implement Standard Operating Procedures (SOPs) and quality documentation.
- Establish and maintain quality management systems for non-sterile compounding operations.
- Oversee laboratory design, workflow planning, and equipment selection to ensure compliance with regulatory requirements.
- Conduct staff training on compounding techniques, quality assurance, safety protocols, and regulatory compliance.
- Prepare the facility for regulatory inspections and audits while maintaining inspection readiness.
- Monitor and continuously improve compounding processes, documentation, and quality standards.
- Collaborate with cross-functional teams to ensure operational excellence and regulatory compliance.
Education
- Bachelor's Degree in Pharmacy.
- Must be a Licensed Pharmacist.
- Formal training or certification in USP <795>, USP <797>, and USP <800> standards is highly preferred.
Experience
- 8–10+ years of pharmacy or pharmaceutical industry experience.
- Extensive hands-on experience in pharmaceutical compounding.
- Direct involvement in at least one compounding laboratory or pharmacy build-out from planning through operational readiness.
- Experience with FDA License to Operate (LTO) applications and regulatory compliance.
- Experience developing SOPs, quality systems, and documentation.
- Proven experience preparing facilities for regulatory inspections and audits.
