Head of Sterile Compounding

The-Pharmacy-Hub; Miami Gardens (FL); Presencial; USD 185.000 - 225.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision coverage

401(k) with 100% match up to 4%

7 holidays + PTO with rollover

Increased PTO yearly

Descripción de la vacante

The Pharmacy Hub is building a modern sterile compounding operation in Florida and seeks a pharmacist leader to build, run, and continuously improve the program from the ground up. You will lead a multidisciplinary team across operations, quality, compliance, and engineering to scale sterile production, ensure regulatory compliance, and drive continuous improvement.

Ideal candidates have 10+ years in sterile compounding and a track record of implementing quality systems, training, and scalable

Formación

• Experience building or expanding a sterile compounding program.
• Extensive knowledge of USP <797> and USP <800>.
• Strong quality-system, cleanroom, and regulatory-inspection experience.

Responsabilidades

• Lead the sterile compounding program buildout from design to operational readiness and scale.
• Mentor and lead a high-performing team of pharmacists, technicians, and quality staff.
• Ensure USP <797>/<800> compliance and translate regulations into workflows for frontline staff.
• Develop and oversee the pharmaceutical quality system (deviations, CAPA, change control, investigations).
• Partner with facilities, engineering, and compliance on cleanroom design and qualification.
• Design sterile production workflows, establish KPIs and dashboards for production metrics.
• Collaborate on formulation development for injectable and sterile formulations.
• Build sterile training programs and competency assessments for ongoing staff development.
• Maintain inspection readiness for Board of Pharmacy, FDA, and accreditation.
• Integrate sterile workflows into ERP and quality dashboards.

Conocimientos

Sterile compounding program

USP <797> & USP <800>

Quality systems

Regulatory inspections

Pharmacist team management

Aseptic processing

Educación

PharmD or BS in Pharmacy

Descripción del empleo

At The Pharmacy Hub, we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver essential products directly to patients. Our expertise allows us to seamlessly distribute pharmaceuticals, medical devices, and other healthcare products to consumers, ensuring greater accessibility and convenience.

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

Pay Range

$185,000 - $225,000 USD

The Pharmacy Hub Cares:

• Medical, dental, and vision coverage
• 401(k) plan that matches 100% up to 4%, with immediate vesting
• 7 Holidays + Paid Time Off Accrual + Rollover Plan
• Commitment matters at The Pharmacy Hub! Increased PTO every year

Core Values

The Pharmacy Hub is dedicated to breaking barriers in healthcare by championing access, intervention and affordability.

• Customer-first mindset - we develop strong partnerships with telehealth platforms and healthcare companies to enhance access and understand their specific needs
• Innovation for intervention in care - we develop advanced compounding solutions and products to better support patient health outcomes
• Continuous improvement - we continuously improve our processes and offerings through intelligent, honest and transparent practices to deliver cost-effective solutions that truly benefit our clients and their patients.

You will play a pivotal role in maintaining these values and contributing to the company’s mission of redefining healthcare delivery through superior pharmacy services

At The Pharmacy Hub, we don’t just offer jobs—we offer opportunities for career growth and development. We take pride in our fast-paced, team-driven culture and are committed to supporting our employees in achieving success.

The Pharmacy Hub is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Applicants requiring a reasonable accommodation to participate in the hiring process are encouraged to indicate this in their application.

The Pharmacy Hub participates in E-Verify. A post-offer background check is required for all positions. Additional pre-employment screenings may apply depending on the role.