Director of Pharmacy Operations

EmergencyMD; Spring (TX); On-site; USD 150,000 - 190,000; Full time

Job summary

Apex Pharmacy Solutions in Spring, TX seeks a Director of Operations to lead sterile and non-sterile compounding across the organization. You will drive production, process engineering, and facility readiness while ensuring regulatory compliance and batch output goals.

This leadership role partners with QA, procurement, and executive leadership to advance operational excellence. The ideal candidate has 7+ years in pharmaceutical compounding or manufacturing ops, deep USP / knowledge, and a

Qualifications

• Bachelor's degree in Business Administration, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field required.
• MBA, MHA, or equivalent advanced degree strongly preferred.
• Minimum seven years of experience in pharmaceutical compounding or manufacturing operations, with at least three years in a senior leadership role.
• Experience in 503A or 503B compounding facilities preferred.
• Demonstrated track record managing sterile and non-sterile drug production in compliance with USP and state boards.

Responsibilities

• Provide strategic leadership to sterile and non-sterile compounding teams, upholding safety, efficiency, and product quality.
• Drive production schedule adherence and resource allocation to meet prescription demand and turnaround times.
• Own batch record execution, in-process controls, and production KPIs (throughput, yield, cycle time, labor productivity).
• Identify and eliminate bottlenecks to scale capacity while maintaining compliance and safety.
• Establish and continuously improve SOPs for compounding, cleaning, and environmental monitoring.

Skills

Strategic leadership

Production planning

Lean

Six Sigma

Automation

High-throughput systems

Education

Bachelor's degree in Business Admin/Pharmaceutical Sciences/Chemistry/Biochemistry

MBA or equivalent advanced degree

Tools

Pioneer

Pestle

Job description

Summary

Apex Pharmacy Solutions, a Texas-licensed 503A Class Sterile Compounding Pharmacy headquartered in Spring, Texas, specializes in wellness optimization, peptide therapy, longevity medicine, and performance-based medicine. The Director of Operations is a senior leadership role responsible for directing both sterile and non-sterile compounding operations across the organization. This position drives optimization of compounding workflows, scaling of production capacity, regulatory-compliant batch output, maintenance of aseptic conditions, and development of a high-performance compounding team. The ideal candidate brings deep expertise in pharmaceutical compounding, fluent command of USP <795> and USP <797> standards, and a demonstrated track record in pharmacy operations management at scale. Reporting to the Chief Operating Officer (COO), the Director of Operations partners cross-functionally with the Pharmacist-in-Charge, Quality Assurance, Procurement & Warehouse, and executive leadership to advance Apex's operational excellence, regulatory standing, and growth.

Responsibilities

Production Management

• Provide strategic leadership to sterile and non-sterile compounding teams, upholding the highest standards of safety, efficiency, and product quality.
• Drive production schedule adherence and resource allocation to meet prescription demand, turnaround times, and patient delivery SLAs.
• Own batch record execution, in-process controls, and production KPIs including throughput, yield, cycle time, and labor productivity.
• Identify and eliminate bottlenecks across production workflows to scale capacity while maintaining compliance and safety standards.
• Establish, implement, and continuously improve Standard Operating Procedures (SOPs) for compounding, cleaning, and environmental monitoring.

Process Engineering & Scale-Up

• Ensure continuous compliance with applicable federal and state regulations, including USP <795>, USP <797>, Texas State Board of Pharmacy (TSBP) requirements, and FDA guidance applicable to 503A pharmacies.
• Lead the development, validation, and continuous improvement of compounding processes, ensuring reproducibility, efficiency, and regulatory alignment.
• Partner with compounding and clinical staff to transition pilot formulations into scalable, production-ready processes.
• Oversee equipment qualification (IQ/OQ/PQ) and capacity planning for new production lines, cleanroom expansions, and automation integration.

Facility & Cleanroom Oversight

• Maintain full operational control of sterile compounding suites, ensuring adherence to ISO classification standards and environmental control requirements.
• Enforce gowning, cleaning, disinfection, and aseptic technique standards in accordance with USP <797>.
• Direct facility readiness for regulatory audits, planned shutdowns, and preventive maintenance cycles.
• Drive innovation in formulations, process optimization, and operational scalability while preserving patient-specific customization standards.

Regulatory & Manufacturing Compliance

• Ensure all production activities comply with 503A regulatory requirements, USP <795> and USP <797> guidelines, and applicable NABP and TSBP standards.
• Direct the preparation and accuracy of batch production records, compounding logs, and cleaning validation documentation.
• Partner with Quality Assurance and Quality Control on product release testing, deviation investigations, corrective and preventive actions (CAPA), and documentation audits.

Workforce Development

• Recruit, hire, train, and lead a high-performing team of compounding technicians, production supervisors, and support staff across all 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.

Requirements

Education

• Bachelor's degree in Business Administration, Pharmaceutical Sciences, Chemistry, Biochemistry, or related scientific field required.
• MBA, MHA, or equivalent advanced degree strongly preferred.

Experience

• Minimum seven years of experience in pharmaceutical compounding, manufacturing operations, or pharmacy business operations, including at least three years in a senior leadership capacity.
• Prior experience within a 503A or 503B compounding pharmacy facility strongly preferred.
• Demonstrated track record managing sterile and non-sterile drug production in compliance with USP and state board standards.
• Direct experience leading large-scale batch production and cleanroom operations.

Technical Skills

• In-depth working command of USP <795>, USP <797>standards, FDA 503A guidance, and Texas State Board of Pharmacy regulations.
• Familiarity with Lean, Six Sigma, or comparable continuous improvement methodologies.
• Experience with automation, robotics, or high-throughput compounding systems.
• Proficiency with pharmacy production software platforms such as Pioneer, Pestle, or equivalent.
• Experience leading or supporting facility expansion, including scaling operations, equipment relocation, and maintaining compliance throughout transitions.

Professional Competencies

• Demonstrated strategic leadership balanced with operational discipline and tactical execution.
• Strong financial acumen with the ability to manage departmental budgets, analyze cost drivers, and build the business case for capital investments.
• Proven capability to build, develop, and retain high-performing operational teams across multiple shifts.
• Effective executive communicator able to interact professionally with internal teams, regulatory personnel, and senior leadership.
• High degree of integrity and discretion in handling sensitive pharmaceutical, financial, and proprietary information.

Physical Requirements

• Extended periods of standing, walking, and movement throughout the production floor and cleanroom suites.
• Capacity to wear required PPE and sterile garbing for extended durations.
• Ability to lift and transport up to 25 pounds.
• Manual dexterity sufficient to operate compounding equipment, computer systems, and standard production tools.

Work Environment

• Onsite, in-person role at the Apex facility in Spring, Texas.
• Pharmacy production and ISO-classified cleanroom environment within a Texas-licensed 503A Class Sterile Compounding Pharmacy.
• Routine presence on the production floor; required adherence to gowning, PPE, hygiene, and access-control protocols.

Occasional extended hours during high-volume production cycles, regulatory inspections, audits, or facility transitions.