Director of Compounding Pharmacy Operations

We are seeking an experienced and driven Director of Compounding Operations to lead and oversee both sterile and non-sterile compounding activities within a 503A pharmacy setting. This senior leadership role is responsible for optimizing compounding workflows, scaling production capacity, ensuring regulatory-compliant batch output, maintaining aseptic conditions, and building a high-performance compounding team.

The ideal candidate brings deep expertise in pharmaceutical compounding, thorough knowledge of USP <795>, <797>, and <800> standards, and a demonstrated track record in pharmacy operations management at scale.

KEY RESPONSIBILITIES

Production Management

• Provide strategic leadership to sterile and non-sterile compounding teams, upholding standards of safety, efficiency, and product quality.

• Drive production schedule adherence and resource allocation to meet prescription demand, turnaround times, and patient delivery SLAs.

• Oversee batch record execution, in-process controls, and production KPIs including throughput, yield, cycle time, and productivity.

• Proactively identify and eliminate bottlenecks in production workflows to increase capacity while maintaining compliance and safety standards.

• Establish, implement, and continuously improve SOPs for compounding, cleaning, and environmental monitoring.

Process Engineering & Scale-Up

• Ensure full compliance with all applicable federal and state regulations, including USP <795>, <797>, <800>, DEA regulations, and state board of pharmacy requirements.

• Lead the development, validation, and continuous improvement of compounding processes-ensuring reproducibility, efficiency, and regulatory alignment.

• Collaborate with R&D and formulation staff to transition pilot formulations into scalable, production-ready processes.

• Oversee equipment qualification (IQ/OQ/PQ) and capacity planning for new lines, cleanroom expansions, or automation integration.

Facility & Cleanroom Oversight

• Maintain full operational control of sterile and non-sterile compounding suites, ensuring adherence to ISO classification standards and environmental control requirements.

• Enforce proper gowning, cleaning, and disinfection procedures and overall aseptic technique in accordance with USP <797> and <800>.

• Supervise facility readiness for audits, planned shutdowns, and preventative maintenance cycles.

• Drive innovation in formulations, process optimization, and scalability while maintaining patient-specific customization standards.

Regulatory & Manufacturing Compliance

• Ensure all production activities comply with state and federal 503A requirements, USP <795>, <797>, <800>, DEA guidelines, and applicable FDA guidance.

• Oversee preparation of batch production records, compounding logs, and cleaning validation documentation.

• Partner with QA/QC to manage product release testing, deviation investigations, CAPAs, and documentation audits.

Workforce Development

• Recruit, hire, train, and lead a team of compounding technicians, production supervisors, and support staff across shifts.

• Set clear performance goals and mentor team members on aseptic technique, operational efficiency, and GMP mindset.

• Foster a culture of safety, accountability, and pride in production excellence.

QUALIFICATIONS & REQUIREMENTS

Education & Experience

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific field required; MBA or MHA preferred.

• 7+ years of experience in pharmaceutical or compounding manufacturing operations, or business operations, including 3+ years in a leadership capacity-preferably within a 503A facility.

• ACPE IV Certification required.

• In-depth knowledge of USP <795>, <797>, and <800> guidelines.

• Demonstrated expertise managing sterile and non-sterile drug production in compliance with USP and state board standards.

• Experience leading large-scale batch production, aseptic manufacturing, and cleanroom operations.

Preferred Skills

• Familiarity with Lean, Six Sigma, or other process improvement methodologies.

• Experience with automation, robotics, or high-throughput compounding systems.

• Proficiency with production software platforms such as Pioneer, Pestle, or equivalent.

Experience leading or supporting a facility expansion-including scaling operations, equipment relocation, and maintaining compliance throughout the transition

Pay: $130,000.00 - $175,000.00 per year

Education:

• Bachelor's (Required)

Experience:

• Pharmaceutical, Compounding or Business Operations: 7 years (Required)

Work Location: In person