Head of Operations – 503A Sterile Compounding Pharmacy Build

Barrington James; California (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

A private equity-backed healthcare platform is seeking a Founding Operations Leader for a new sterile compounding pharmacy in California. This role involves leading the operational build and launch of the pharmacy, ensuring compliance with USP standards, and shaping workflows and systems. Ideal candidates will have senior leadership experience in sterile compounding pharmacy operations and a strong understanding of cleanroom practices. This is an opportunity to design and build a pharmacy from the ground up.

Qualifications

• Senior leadership experience in sterile compounding pharmacy operations required.
• Deep knowledge of USP <797>, USP <795>, and USP <800> standards essential.
• Experience designing sterile compounding workflows or pharmacy operations is needed.

Responsibilities

• Lead the operational build and launch of a 503A sterile compounding pharmacy.
• Support facility design, cleanroom workflow, and sterile compounding operations.
• Establish operational systems and SOP frameworks.

Skills

Leadership in sterile compounding pharmacy operations

Knowledge of USP <797>, USP <795>, USP <800>

Designing sterile compounding workflows

Understanding of cleanroom operations

Operating in a startup environment

Job description

We are currently supporting a private equity–backed healthcare platform building a new 503A sterile compounding pharmacy in California that is looking to engage a Founding Operations Leader.

This is a greenfield build where the selected individual will play a key role in designing, building, and launching the operational foundation of the pharmacy. The organization is looking for a senior sterile compounding leader who understands pharmacy operations, facility design, regulatory compliance, and the business side of compounding pharmacy growth.

This person will work closely with ownership to help shape the concept, workflows, operational systems, and long-term operating model of the pharmacy.

This is not a maintenance role within an established pharmacy. This is a build-from-scratch leadership opportunity within a regulated sterile compounding environment.

Responsibilities

• Lead the operational build and launch of a 503A sterile compounding pharmacy
• Support facility design, cleanroom workflow, and sterile compounding operations
• Establish operational systems, SOP frameworks, and pharmacy workflows
• Ensure compliance with USP <797>, USP <795>, and USP <800> standards
• Partner with ownership on operational strategy and long‑term growth
• Help recruit and build the initial pharmacy leadership and operations team
• Support launch readiness with inspection‑ready processes and documentation

Required Experience

• Senior leadership experience in sterile compounding pharmacy operations
• Deep knowledge of USP <797>, USP <795>, and USP <800>
• Experience designing or building sterile compounding workflows or pharmacy operations
• Strong understanding of cleanroom operations and aseptic compounding
• Ability to operate in a startup or build‑phase environment

This is a rare opportunity to help design and build a sterile compounding operation from the ground up and play a foundational role in shaping the future of the business.