About Southend Pharmacy
Southend Pharmacy is a modern 503A compounding pharmacy built on clinical precision, operational clarity, and a human-first approach. Licensed in 35+ states and focused on longevity-aligned therapeutics, we support providers and their patients with precision in compounding and transparent processes. Southend Pharmacy operates at the intersection of innovation, ambition, and clinical excellence—blending precision, clarity, and compassionate support to help providers deliver patient-centered, clinically guided care across every step of the treatment journey.

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.

Key Responsibilities

• Production Management
  • 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
• Process Engineering & Scale Up
  • 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
• 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, 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
• 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
  • 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

What We Require

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

Physical Requirements

• Work is performed in cleanroom, lab, and office environments
• PPE required; frequent standing, gowning, and cleanroom access
• Flexibility to respond to urgent operational needs outside of standard business hours

What We Offer

• Full benefits package including medical, vision, dental, 401(k) with company match, PTO, Flex days, holidays, and more!

Southend Pharmacy does not provide employment visa sponsorship now or in the future. Applicants must be legally authorized to work in the United States without the need for current or future sponsorship.

Equal Opportunity Employer Statement
Southend Pharmacy is proud to be an Equal Opportunity Employer where we are committed to fostering a diverse and inclusive workplace. We are committed to cultivating a culture where all team members feel valued & respected. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetic information, disability, age, veteran status, or any other characteristics protected by applicable law.

If you have any questions or require immediate assistance or accommodations during the application or interview process, please contact us at recruiting@alliahealth.co.