Director Of Development Operations Jobs in Spring, TX

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.

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.

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.

• 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.

• 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.