Pharmacist

Position Summary

The Pharmacist oversees daily sterile and non-sterile compounding operations, clinical evaluations, and regulatory compliance at the Nashville facility. Working within a high-autonomy, fast-paced setting, this role ensures all compounded sterile and non-sterile preparations (CSPs) meet stringent quality standards and comply with USP <795>, USP <797>, USP <800>, and Tennessee Board of Pharmacy regulations. The role requires direct supervision of pharmacy technicians, rigorous adherence to cleanroom operational controls, and active participation in quality assurance protocols.

Essential Duties and Responsibilities

1. Clinical Verification & Compounding Operations

● Perform final clinical and technical verification of all compounded sterile and non-sterile preparations (CSPs), ensuring adherence to Master Formulation Records, Beyond-Use Dating (BUD), and labeling specifications.

● Review medication orders for clinical appropriateness, dosing accuracy, osmolarity, physical/chemical compatibility, and stability.

● Supervise Certified Sterile and Non-sterile Compounding Pharmacy Technicians in daily cleanroom workflows, aseptic preparations, and compounding techniques.

● Manage handling, preparation, and disposal of hazardous drugs in accordance with USP <800> guidelines.

2. Quality Assurance, Environmental Monitoring & Compliance

● Enforce adherence to USP <795>, USP <797> and USP <800>, Section 503A regulations, and State of Tennessee pharmacy laws.

● Oversee cleanroom environmental monitoring programs, including air and surface sampling, differential pressure logs, temperature tracking, and sanitization schedules.

● Maintain complete, audit-ready documentation for media-fill tests, gloved fingertip testing, equipment calibration, and batch production records.

● Investigate out-of-specification results, environmental excursions, or compounding errors; implement root-cause analysis and Corrective and Preventive Actions (CAPA).

3. Inventory & Facility Management

● Maintain oversight of Active Pharmaceutical Ingredients (APIs), sterile and non-sterile components, and specialized equipment.

● Ensure proper storage, handling, and security of controlled substances and Legend drugs.

● Perform additional operational duties, continuous quality improvement (CQI) projects, or technical initiatives as assigned by management.

Required Qualifications

● Education: Doctor of Pharmacy (Pharm.D.) or Bachelor of Science in Pharmacy from an ACPE-accredited institution.

● Licensure: Active, unrestricted License to practice pharmacy issued by the Tennessee Board of Pharmacy (or active licensure eligible for immediate reciprocity). Preferred licensure in other states.

● Experience: Minimum of 2 years of direct sterile and non-sterile compounding experience in an ISO-classified cleanroom setting (503A specialty compounding, 503B outsourcing facility, or health-system IV cleanroom).

Knowledge, Skills, and Abilities

● In-depth knowledge of USP <795>, USP <797>, USP <800>, and Tennessee pharmacy jurisprudence.

● Advanced expertise in aseptic technique, compounding calculations, and environmental monitoring protocols.

● Ability to operate independently with minimal direct supervision in a fluid, high-autonomy setting.

● Strong written and verbal communication skills for cross-functional collaboration.

Physical & Environmental Demands

● Frequent standing, bending, and reaching inside laminar airflow workbenches and biosafety cabinets.

● Ability to work inside cleanroom environments requiring full personal protective equipment (PPE) garb (gowns, masks, gloves, eye protection) for extended durations.

● Ability to lift up to 30 lbs of pharmacy inventory or supplies as necessary.

Pay: From $130,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• Do you have an active, unrestricted license to practice pharmacy issued by the Tennessee Board of Pharmacy?
• How many years of experience do you have of direct sterile and non-sterile compounding experience in an ISO-classified cleanroom setting?
• Do you have a Doctor of Pharmacy (Pharm.D.) or Bachelor of Science in Pharmacy from an ACPE-accredited institution?

Work Location: In person