Pharmacist

Pay: $60.75 - $70.15 per hour

Job description:

Pharmacist in Charge (PIC)

503A Compounding Pharmacy — Utah Licensed Facility

Reports To: Owner

Location: American Fork, Utah — on-site, full time

License Required

Active Utah Pharmacist License (RPh) — mandatory, non-negotiable

Position Summary:

The Pharmacist in Charge (PIC) is the licensed pharmacist who bears individual responsibility, under Utah Admin. Code R156-17b-501 and the Utah Pharmacy Practice Act, for the safe and lawful operation of the company's 503A compounding pharmacy. The PIC ensures all compounding activities comply with USP <795>, <797>, and <800> standards, Utah Board of Pharmacy rules, and applicable FDA guidance on compounding with bulk drug substances. In Nexiuum's combined facility model, the PIC works in close coordination with the Designated Representative (DR) for the co-located Class C wholesale distribution operation, ensuring the two licensed activities remain properly segregated and independently compliant.

Statutory Qualifications:

a. Holds a current, active pharmacist license issued by the Utah Division of Professional Licensing (DOPL) — Utah RPh license in good standing, no restrictions.

b. Is designated as the PIC on the pharmacy's Utah Board of Pharmacy license application and all related DOPL filings.

c. Is physically present at the pharmacy during regular operating hours, or has a designated pharmacist-in-charge designee who assumes responsibility during authorized absences.

d. Is actively responsible for and involved in the daily operation of the pharmacy, including oversight of all compounding, dispensing, recordkeeping, and compliance activities.

e. Has completed, or commits to complete within a Board-required timeframe, continuing education in sterile and/or non-sterile compounding as applicable to the pharmacy's scope.

Key Responsibilities:

Serve as the named Pharmacist in Charge on the Utah 503A pharmacy license and all DOPL filings; maintain license in active, unrestricted standing.

Provide direct supervision and oversight of all non-sterile (USP <795>) and sterile (USP <797>) compounding activities performed at the facility.

Establish, implement, and enforce all pharmacy standard operating procedures (SOPs) covering compounding, beyond-use dating (BUD), labeling, dispensing, and patient safety.

Ensure full compliance with USP <795>, <797>, and <800> (hazardous drug handling) standards, including environmental monitoring, personnel training, and cleanroom qualification.

Maintain complete, accurate, and audit-ready compounding records including formulation records, compounding logs, ingredient lot tracking, and prescription records as required by Utah law.

Oversee drug procurement and inventory management, including verification of supplier credentials, certificate of analysis (CoA) review for bulk drug substances, and controlled substance accountability. Serve as the primary point of contact for Utah Board of Pharmacy inspections, audits, and investigations; ensure facility and records are inspection-ready at all times. Manage the facility's compliance with FDA bulk drug substance guidance for 503A compounding, including monitoring the FDA Category 1/Category 2 bulk substance lists and ensuring compounding activities remain within lawful scope. Coordinate with the Designated Representative (DR) of the co-located Class C wholesale operation to maintain clear operational and physical segregation between compounding and wholesale distribution activities. Oversee DEA controlled substance registration for the pharmacy, including biennial inventory, ordering, recordkeeping, and disposal compliance. Hire, train, supervise, and evaluate pharmacy technicians and compounding staff; ensure all personnel meet Utah licensure, training, and competency requirements. Maintain and execute the pharmacy's quality assurance (QA) program, including batch testing protocols, failed batch procedures, and complaint/adverse event tracking. Oversee patient and prescriber communications as required, including counseling obligations and prescription verification.

Monitor and implement changes to USP standards, Utah Board of Pharmacy rules, and FDA guidance affecting compounding scope or practice; communicate material changes to operations leadership promptly. 503A Compounding Scope & FDA Bulk Substance Compliance

Nex Level Pharmacy 503A pharmacy operates under FDA's compounding framework for patient-specific prescriptions. The PIC is responsible for ensuring compounding activities remain within the lawful scope of 503A, including:

Monitoring the FDA 503A Bulk Drug Substances list (Category 1 — nominated and appropriate for compounding; Category 2 — withdrawn or not appropriate) and restricting compounding to substances on the Category 1 list or with a valid USP monograph. Ensuring peptides and other complex molecules compounded at the facility are lawfully permissible under current FDA guidance, and discontinuing or modifying formulations in response to FDA category changes. Maintaining documentation that each compounded preparation is dispensed pursuant to a valid patient-specific prescription from a licensed prescriber — not for office stock or wholesale distribution. Ensuring the facility does not exceed the 503A patient-specific prescription model in a manner that would trigger 503B outsourcing facility requirements. Combined Facility Coordination (503A Class C)

Work directly with the Designated Representative (DR) to maintain physical, operational, and recordkeeping separation between the 503A pharmacy and the Class C wholesale distribution operation, as required by Utah DOPL and FDA. Participate in joint compliance reviews and facility inspections that may cover both licensed operations.

Align on shared facility resources (cleanroom access, HVAC, controlled substance storage) with the DR to ensure no activity of one licensed entity creates a compliance risk for the other. Coordinate with operations leadership on the facility buildout to ensure cleanroom design, segregated storage, and workflow meet the requirements of both 503A and Class C licensure simultaneously.

Required Qualifications:

Active, unrestricted Utah pharmacist license (RPh) issued by DOPL — required on day one; no exceptions. Minimum 2–3 years of post-licensure experience, with demonstrated compounding experience (sterile and/or non-sterile depending on facility scope). Working knowledge of USP <795>, <797>, and <800> standards and their application in a compounding pharmacy environment. Familiarity with Utah Pharmacy Practice Act rules (Title R156-17b) and Utah Board of Pharmacy operating standards for 503A facilities.

Ability to pass DOPL-required background check. Strong SOP development, documentation, and inspection-readiness skills. Comfortable serving as the named regulatory signatory and point of contact with the Utah Board of Pharmacy and DEA. Preferred Qualifications

Prior PIC experience at a 503A compounding pharmacy. Experience compounding peptides, hormone preparations, or other complex formulations.

Familiarity with FDA 503A bulk drug substance guidance and the Category 1/2 designation framework. PCAB (Pharmacy Compounding Accreditation Board) accreditation experience or involvement in a PCAB accreditation process. Experience managing a combined or co-located licensed facility (compounding distribution or 503A 503B). Bilingual (English/Spanish) a plus given workforce composition. Experience with cleanroom qualification, environmental monitoring programs, and USP <800> hazardous drug compliance.

Compensation:

Base salary range: Salary and equity opportunity, commensurate with experience and scope. Benefits package to be confirmed.

Work Environment & Physical Requirements;

On-site presence required during pharmacy operating hours; remote work not permissible under Utah Board of Pharmacy rules for PIC designation.

Cleanroom and controlled environment work; must be able to gown, follow aseptic technique, and operate in ISO-classified spaces as required by facility scope.

Exposure to hazardous drug handling environments (USP <800>); appropriate PPE and training provided. Must be available for unannounced Utah Board of Pharmacy inspections during operating hours.

Benefits:

Health insurance

Paid time off

Work Location: In person