Director of Compounding Operations

AP MAX INC•Houston, TX

About The Position

We are seeking an experienced Director of Compounding Operations to lead and oversee both sterile and non-sterile compounding activities within a 503A pharmacy setting. This 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 will bring significant expertise in pharmaceutical compounding, regulatory standards (USP <795>, <797>, <800>), and pharmacy operations management.

Requirements

7+ years of experience in pharmaceutical or compounding manufacturing operations, including 3+ years in a leadership capacity, preferably within a 503A facility
In-depth knowledge of USP <795>, <797>, and <800> guidelines
Demonstrated experience managing cleanroom operations, audits, and pharmacy staff
ACPE IV Certification
Demonstrated expertise in 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
Familiarity with Lean, Six Sigma, or other process improvement methodologies
Experience with automation, robotics, or high-throughput compounding systems
Familiarity with production software (Pioneer, Pestle, etc )

Nice To Haves

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

Responsibilities

Provide strategic leadership to sterile and non-sterile compounding teams, ensuring high 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 remove bottlenecks in production workflows to increase capacity while maintaining compliance and safety standards
Establish, implement, and continuously improve SOPs (Standard Operating Procedures) for compounding, cleaning, and environmental monitoring
Ensure full compliance with all applicable federal and state laws, 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/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
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, disinfection procedures and overall aseptic technique in accordance with USP <797> and <800>
Supervise facility readiness for audits, shutdowns, or preventative maintenance
Drive innovation in formulations, process optimization, and scalability while maintaining patient-specific customization standards
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
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