Job SummaryThe Lead Sterile Compounding Pharmacist is responsible for overseeing sterile compounding operations within a 503A compounding pharmacy, ensuring the safe, accurate, and compliant preparation, verification, and dispensing of sterile medications. This role serves as the onsite pharmacy leader for sterile operations, providing guidance to pharmacists and technicians while maintaining compliance with USP , USP , Texas State Board of Pharmacy regulations, and internal quality standards. The position plays a critical role in supporting cleanroom operations, regulatory readiness, staff development, and operational excellence.
Please note that this morning shift schedule is Monday through Friday from 6:00 AM to 2:30 PM; however, hours may be adjusted based on business needs, and flexibility in availability is expected to support teams and operational demands.
Key ResponsibilitiesOperational Leadership- Lead daily workflow of sterile compounding operations in a 503A compounding pharmacy, ensuring timely and accurate compounding processes
- Provide onsite leadership, coaching, and training to pharmacy technicians and support staff
- Serve as acting pharmacy leader when the Pharmacy Manager is unavailable
- Partner with leadership on staffing, scheduling, and operational improvements
Operational and Compounding Oversight Duties- Plan daily compounding production activities based on product demand
- Oversee sterile compounding procedures in accordance with USP standards ( and )
- Ensure cleanroom procedures, aseptic technique, and environmental monitoring practices are followed
- Oversee inventory management for medications and supplies related to hazardous sterile medication compounding
- Utilize strategy and critical thinking to improve workflows and team efficiency
Regulatory & Compliance- Maintain compliance with 503A compounding regulations and demonstrate working knowledge of 503B requirements
- Adhere to Texas State Board of Pharmacy (TSBP) regulations, DEA regulations, FDA guidelines, and internal SOPs
- Ensure meticulous documentation and oversight of controlled substances and sterile compounding logs
- Support audit readiness and lead corrective actions when compliance deviations are identified
Quality Assurance & Process Optimization- Identify workflow improvements for safety, efficiency, and accuracy within the compounding environment
- Assist with root-cause analysis and quality assurance initiatives
- Monitor key operational metrics: accuracy, sterility compliance, productivity, and turnaround times
Collaboration & Communication- Partner with clinical teams and internal departments to ensure seamless compounding and dispensing operations
- Support technician training in sterile compounding, handling of hazardous drugs, gowning protocols, and SOP adherence
- Communicate operational needs, risks, and updates to leadership promptly
Required Qualifications- PharmD or Bachelor of Science in Pharmacy from an accredited institution.
- Active Texas Pharmacist License in good standing.
- Minimum 5 years of pharmacist experience, including at least 3 years in sterile compounding operations.
- Extensive knowledge of USP , USP , aseptic technique, environmental monitoring, and cleanroom operations.
- Previous experience serving as a Lead Pharmacist, Pharmacist-in-Charge, Supervisor, or pharmacy leadership role.
- Demonstrated experience supervising and training pharmacy technicians in sterile compounding environments.
- Strong understanding of 503A pharmacy regulations; familiarity with 503B standards preferred.
- Experience with pharmacy management systems and compounding workflow processes.
- Ability to work onsite in a fast-paced, high-volume sterile compounding environment.
Preferred Qualifications- Experience in both 503A and 503B compounding pharmacies.
- Experience supporting environmental monitoring programs, media fill testing, and quality assurance initiatives.
- Background in sterile injectable medications, hormone therapy, weight management formulations, or specialty pharmacy services.
- Previous experience leading compliance audits, investigations, CAPA programs, and process improvement initiatives.
Physical Requirements- Ability to sit for extended periods of time at a desk and working on a computer
- Ability to communicate effectively in person, over the phone, or via virtual meeting
- Ability to maintain focus in a typical office environment with moderate noise levels
- Ability to perform repetitive motions with hands and arms, such as typing.
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.
