Director of Operations
On-siteTexas, United States
Job Summary
Direct sterile and non-sterile compounding operations across the organization, driving production schedule adherence, batch record execution, and throughput KPIs. Lead process engineering and scale-up by validating compounding workflows, overseeing equipment qualification, and transitioning pilot formulations into scalable production. Maintain full operational control of ISO-classified cleanroom suites, enforcing aseptic standards and environmental monitoring while ensuring compliance with USP <795>, USP <797>, and Texas State Board of Pharmacy regulations. Recruit, train, and lead a high-performing team of technicians and supervisors, managing departmental budgets and fostering a culture of safety and operational excellence. Report to the Chief Operating Officer and partner cross-functionally with Quality Assurance and executive leadership to advance regulatory standing and growth.
Required Qualifications
- Bachelor's degree in Business Administration, Pharmaceutical Sciences, Chemistry, Biochemistry, or related scientific field
- Minimum seven years of experience in pharmaceutical compounding, manufacturing operations, or pharmacy business operations
- At least three years in a senior leadership capacity
- In-depth working command of USP <795>, USP <797> standards, FDA 503A guidance, and Texas State Board of Pharmacy regulations
- 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
- 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
- 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
Desired Qualifications
- MBA, MHA, or equivalent advanced degree
- Prior experience within a 503A or 503B compounding pharmacy facility
- 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 LifeFile, Pioneer, Pestle, or equivalent
- Experience leading or supporting facility expansion, including scaling operations, equipment relocation, and maintaining compliance throughout transitions
- 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
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