Compounding Laboratory Consultant

About the role

We are looking for an experienced Licensed Pharmacist to lead the creation and operation of a fully compliant pharmaceutical compounding laboratory. The role requires deep expertise in compounding practices, quality systems, and regulatory affairs, with a focus on establishing a state‑of‑the‑art facility.

Key responsibilities

• Plan, design, and launch pharmaceutical compounding laboratories.
• Ensure ongoing compliance with USP <795>, USP <797>, and USP <800> standards.
• Prepare and manage FDA License to Operate (LTO) applications and related regulatory submissions.
• Develop, review, and implement SOPs and quality documentation.
• Build and maintain quality management systems for non‑sterile compounding.
• Oversee laboratory layout, workflow planning, and equipment selection to meet regulatory requirements.
• Conduct staff training on compounding techniques, safety, and compliance.
• Maintain inspection readiness and lead preparation for regulatory audits.
• Continuously improve compounding processes, documentation, and quality standards.
• Collaborate with cross‑functional teams to ensure operational excellence.

Required profile

• Bachelor’s degree in Pharmacy and a valid pharmacist license.
• 8‑10+ years of pharmacy or pharmaceutical industry experience.
• Hands‑on experience setting up at least one compounding laboratory from planning to operational readiness.
• Experience with FDA LTO applications and regulatory compliance.
• Proven ability to develop SOPs, quality systems, and prepare facilities for inspections.

Required skills

• USP <795>, USP <797>, USP <800> standards.
• FDA License to Operate (LTO) application process.
• SOP development and documentation.
• Quality management systems for compounding.
• Laboratory design, workflow planning, and equipment selection.
• Staff training on compounding and regulatory compliance.
• Regulatory inspection preparation and audit readiness.