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We are seeking an experienced and highly detail-oriented Lead Sterile Compounding Pharmacist to play a key role in supporting sterile compounding operations within a high-quality pharmacy environment. This individual will serve as a subject matter expert in aseptic processing, providing day-to-day leadership on the compounding floor while ensuring adherence to regulatory standards and internal quality expectations. This role is ideal for a pharmacist who thrives in a hands-on setting, leads by example, and is passionate about maintaining the highest standards of patient safety, compliance, and product quality.
Job Responsibility:
Lead and actively participate in sterile compounding activities, ensuring accuracy, consistency, and adherence to established protocols
Serve as a technical resource for pharmacists and technicians on aseptic technique and compounding best practices
Support daily workflow coordination to ensure timely and efficient preparation of compounded medications
Identify and implement process improvements to enhance throughput, reduce variability, and maintain quality standards
Maintain strict adherence to applicable regulatory standards, including USP <797> and <800>
Support environmental monitoring programs, personnel qualification, and ongoing competency assessments
Assist in the development, review, and continuous improvement of standard operating procedures (SOPs)
Ensure all compounding activities align with internal quality systems and regulatory expectations
Provide guidance, training, and mentorship to pharmacy staff on sterile compounding techniques and compliance requirements
Reinforce best practices related to aseptic technique, hazardous drug handling, and documentation standards
Promote a culture of accountability, precision, and continuous improvement across the compounding team
Partner with quality, compliance, and operations teams to support efficient and compliant workflow execution
Collaborate with pharmacists and clinical teams to address formulation questions and resolve compounding-related challenges
Contribute to investigations, deviations, and corrective actions as needed
Support proper handling, storage, and utilization of APIs, excipients, and compounding supplies
Assist in maintaining inventory levels to support uninterrupted operations while minimizing waste
Requirements:
Doctor of Pharmacy (PharmD) from an accredited institution
Active, unrestricted pharmacist license in good standing (multi-state flexibility preferred)
Minimum of 3+ years of experience in sterile compounding (503A or 503B environment preferred)
Demonstrated expertise in USP <797> and <800> standards and aseptic processing
Strong understanding of compounding workflows, cleanroom operations, and quality systems
Proven ability to operate in a fast-paced, regulated environment with high attention to detail
Nice to have:
Board Certification in Sterile Compounding (e.g., BCSCP) or similar specialization
Experience in high-volume sterile compounding operations
Familiarity with hazardous drug compounding and handling requirements
Exposure to process improvement initiatives (Lean, Six Sigma, or similar)
Prior experience mentoring or leading teams in a hands-on capacity