Head of Sterile Compounding

Job Summary

The Pharmacy Hub is building a modern, high-quality sterile compounding operation, and we're looking for an exceptional sterile compounding pharmacist to build, lead, and continuously improve that operation from the ground up.

This is not simply a pharmacist-in-charge or production pharmacist role. We're looking for a true builder, operator, mentor, and quality leader — someone genuinely passionate about sterile compounding who can create an entire program spanning people, processes, facilities, equipment, quality systems, compliance, formulation development, training, technology, and scalable production.

You'll work cross-functionally with Pharmacy Operations, Quality, Compliance, Engineering, Facilities, Regulatory Affairs, Procurement, R&D, Technology, and executive leadership, and should be comfortable wearing multiple hats during the buildout phase — sterile operations leader, quality leader, pharmacist, trainer, formulation-development partner, compliance expert, and organizational mentor.

Essential Functions and Responsibilities

• Lead program buildout: develop the sterile compounding program from initial design through operational readiness and sustained commercial operations, including the operating model, org structure, staffing plan, training program, and quality infrastructure needed to scale.


• Build and mentor the team: train and lead a high-performing team of pharmacists, technicians, quality personnel, and production leaders, embedding quality, safety, and accountability into daily operations.


• Own USP <797>/<800> compliance: serve as the internal subject-matter expert on USP <797>, USP <800>, Florida Board of Pharmacy sterile-compounding requirements, and applicable DEA/FDA requirements, translating regulations into executable workflows for frontline staff.


• Lead quality systems: develop and oversee the pharmaceutical quality system — deviations, CAPA, change control, investigations, environmental monitoring, and vendor/equipment qualification — and build systems that catch compliance gaps before they become findings.


• Partner on facility and engineering: collaborate with Engineering, Facilities, architects, and contractors on cleanroom design, construction, qualification, and ongoing maintenance, with a strong working knowledge of ISO-classified environments, airflow, HEPA filtration, and contamination control.


• Drive production and scale-up: design sterile production workflows that scale safely, and establish KPIs and dashboards for batch success rate, right-first-time percentage, yield, cycle time, and other production and quality metrics.


• Support formulation development: partner with formulation scientists, analytical scientists, and R&D on injectable, ophthalmic, and other sterile formulations — from initial development through robust, reproducible, scalable processes.


• Train and mentor: build sterile training programs, develop trainers, create competency assessments, and coach team members into future supervisors and managers — staying visible on the floor rather than managing from an office.


• Maintain inspection readiness: keep the operation in a continuous state of inspection readiness and lead preparation for Board of Pharmacy, FDA, and accreditation inspections and audits.


• Modernize systems: partner with Technology and Operations to build sterile workflows into the company's ERP and pharmacy systems, including electronic batch records, barcode verification, and quality dashboards.

Qualifications

• PharmD or BS in Pharmacy


• Active pharmacist license in good standing; ability to obtain Florida pharmacist licensure as required


• Minimum 10 years of progressive sterile compounding, pharmacy operations, quality, compliance, and team-leadership experience

Skills:

• Demonstrated experience building or substantially expanding a sterile compounding program


• Extensive knowledge of USP <797> and USP <800>


• Strong quality-system, cleanroom, and regulatory-inspection experience


• Experience managing pharmacists and pharmacy technicians


• Strong understanding of aseptic processing, environmental monitoring, and contamination-control principles


• Experience with SOP development, CAPA/deviation management, and process improvement at scale

Additional Skills and Competencies

• Experience as a Director of Sterile Compounding, VP of Pharmacy Operations, Director of Quality, Director of Pharmacy, or Sterile PIC


• 503A sterile compounding and/or 503B outsourcing facility experience


• cGMP manufacturing or hospital IV-room leadership experience


• FDA and/or Board of Pharmacy inspection experience


• Facility construction or cleanroom expansion experience


• Process validation, cleaning validation, and equipment qualification experience


• Formulation development, technology transfer, and commercial scale-up experience


• Experience implementing automation or digital quality systems

Technical and Regulatory Environment

• Cleanroom / ISO-classified environment, primary and secondary engineering controls, HEPA filtration,environmental monitoring, aseptic processing. 


• Standards: USP <797> (Sterile Preparations), USP <800> (Hazardous Drugs), Florida Board of Pharmacy requirements, and DEA requirements where controlled substances are involved.

Cognitive and Physical Demands

• Cognitive: High attention to detail, strong analytical and root-cause problem-solving skills, and the ability to lead cross-functional teams through complex, fast-changing priorities.


• Physical: Ability to stand, walk, and move through cleanroom and production environments for extended periods, including gowning/garbing as required.

Leadership Characteristics

We're looking for someone who is people-focused, highly collaborative, extremely accountable, obsessed with quality, and operationally minded — comfortable on the production floor, a natural teacher, a builder, and calm under pressure. Technical expertise alone won't be enough; this person should be as excited about developing people and systems as about the science itself.

Job Type: Full-time, 100% On Site

What We Offer

• Competitive, leadership-level compensation


• Significant influence over the design and direction of a sterile program built from the ground up


• Collaborative, innovative work environment focused on patient safety and compliance