Director of Compounding Pharmacy Operations

2 months ago

Clearwater, United States BodyHealth, LLC Full time
Join BodyHealth – A Dynamic Leader in Nutritional Supplements

At BodyHealth, we're more than just a nutritional supplement company – we're a lifestyle brand committed to enhancing the health and wellness of our customers. Located in beautiful Dunedin, Florida, our rapidly growing team is driven by innovation and excellence.

We pride ourselves on producing the highest quality products designed to support a wide range of individuals, from people seeking just to improve their health and to professional athletes aiming for peak performance. Our supplements are crafted to ensure the body functions at its best, catering to everyone's needs in between.

Our continued success has driven us to expand into a larger facility to accommodate our thriving operations. In just one year, we’re already planning another move to support our growth. We've successfully launched into the retail market, with our products now available on store shelves nationwide, and our eCommerce revenue has tripled. These milestones are just the beginning, and we’re excited for what’s next.

If you’re passionate about health and wellness and eager to contribute to a company that’s making a significant impact, we want you to be part of our journey. Join us at BodyHealth and help us continue to grow and innovate

Job Role:
The purpose of this position is to lead the creation of a sterile compounding lab from the ground up, providing BodyHealth with custom pharmaceutical products to be sold through its appropriate verticals.

Job Summary:
The Compounding Pharmacist will be responsible for leading the development and implementation of BodyHealth’s new sterile compounding lab. This position involves overseeing the entire process of building a 503A facility from the ground up, with the potential to expand into a 503B operation in the future. Key responsibilities include planning and executing the lab build-out, managing financial and personnel resources, ensuring compliance with all regulatory standards, and acquiring necessary equipment and supplies. The goal is to establish a fully functional sterile compounding lab to provide custom pharmaceutical products that align with BodyHealth's operational needs.

Key Responsibilities:

Lab Buildout & Planning:

• Develop a comprehensive plan to design and build a state-of-the-art sterile compounding lab, compliant with 503A standards and with the potential for future 503B certification.
• Collaborate with architects, engineers, and contractors to ensure the lab design meets all required standards (USP 797, USP 800, FDA, and other applicable guidelines).
• Draft a detailed layout for cleanroom design, sterile environments, and other necessary spaces for compounding operations.
• Identify required equipment and technology to meet compounding needs (e.g., laminar flow hoods, cleanroom facilities, compounding isolators, etc.).

Financial Planning:

• Create a comprehensive budget for lab construction, equipment, and ongoing operational costs.
• Provide detailed financial projections and ROI analysis for the initial 503A lab, as well as future expansion into 503B operations.
• Develop cost-saving measures while maintaining compliance with regulatory standards.

Regulatory Compliance & Licensing:

• Ensure the lab adheres to all relevant state and federal regulations, including Good Manufacturing Practices (GMP), FDA, and USP 797/800 standards.
• Oversee the process for obtaining all necessary permits and licenses for sterile compounding (503A) and, potentially, commercial compounding (503B).
• Maintain records and documentation to ensure the lab is ready for audits and inspections.

Supply Chain & Inventory Management:

• Source and manage all necessary compounding ingredients, lab supplies, and equipment.
• Establish relationships with suppliers and negotiate contracts for materials.
• Set up inventory management systems to track supplies and ensure uninterrupted operations.

Personnel Management:

• Coordinate with HR to recruit, hire, and train qualified staff, including pharmacy technicians and support staff for compounding operations.
• Develop standard operating procedures (SOPs) for sterile compounding, staff safety, and regulatory compliance.
• Lead ongoing training and certification for lab personnel to maintain high standards of sterile compounding.

Operational Execution:

• Oversee the implementation of the lab’s buildout plan and ensure timelines and project milestones are met.
• Ensure seamless day-to-day operations of the lab, focusing on quality control, safety, and efficiency in sterile compounding practices.
• Implement quality assurance measures, including sterility testing, environmental monitoring, and batch testing.

Future Expansion to 503B:

• Plan for potential future development of a 503B lab to allow for the production and distribution of compounded drugs for office use.
• Conduct feasibility assessments for the 503B expansion, including cost, regulatory requirements, and market demand analysis.

Qualifications:
• Doctor of Pharmacy (PharmD) degree from an accredited college.
• Current and valid Pharmacist license in Florida.
• Board Certified Sterile Compounding Pharmacist (BCSCP) certification preferred.
• Minimum of 5+ years of experience in sterile compounding, with strong knowledge of 503A and 503B regulations.
• Proven experience in building or managing a compounding lab is preferred.
• Deep understanding of USP 797, USP 800, GMP, and FDA regulations.
• Strong project management skills and ability to execute complex projects from start to finish.
• Excellent leadership, organizational, and communication skills.

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