Sterile Compounding Pharmacist

In2 HR & Talent; New York (NY); On-site; USD 130,000 - 160,000; Full time

Job summary

In2 HR & Talent seeks a Sterile Compounding Pharmacist to lead sterile and non-sterile compounding in a 503A facility, ensuring patient safety and regulatory compliance.

You will manage cleanroom operations, mentor technicians, and drive process improvements while upholding FDA and USP guidelines. A PharmD or BS in Pharmacy with NY license and 2–5 years of leadership in pharmacy are required.

Qualifications

• PharmD or Bachelor of Science in Pharmacy required.
• Active Pharmacist license in New York (additional state licenses a plus).
• 2–5 years of experience with pharmacy technicians or in a leadership role.
• Strong knowledge of FDA, USP <797>, <800>, and <795> guidelines.

Responsibilities

• Oversee sterile compounding operations and adherence to SOPs.
• Supervise compounding technicians and ensure accurate batch records.
• Review batch records and work orders prior to product release.
• Maintain controlled substance logs and compliance documentation.
• Implement CAPA for continuous improvement and training.

Skills

Sterile compounding

Regulatory compliance

Leadership

Education

PharmD or BS in Pharmacy

Job description

A fast-growing sterile/non-sterile compounding pharmacy dedicated to providing high-quality, patient-specific medications in a 503A facility is seeking a Sterile Compounding Pharmacist to lead compounding operations and ensure regulatory compliance while driving process improvements and maintaining a culture of excellence.

Position Overview

The Sterile Compounding Pharmacist will oversee cleanroom compounding activities and provide direct leadership to compounding technicians. This individual will be responsible for work order entry, cleanroom operations, formula and product development, deviation investigations, and batch review prior to product release.

This role requires extensive knowledge of sterile pharmaceutical compounding and a strong understanding of FDA, USP <797>, and USP <800> regulations. The ideal candidate must demonstrate the ability to lead, mentor, and build trust with both internal teams and external partners.

Key Responsibilities

• Oversee daily sterile compounding operations and ensure adherence to Standard Operating Procedures (SOPs) and batch record directions
• Supervise compounding technicians, ensuring compliance with USP <795>, <797>, <800>
• Review batch records and work orders prior to product release
• Manage controlled substance logs and compounding records with accuracy and compliance
• Implement and monitor CAPA (Corrective and Preventive Actions) for continuous improvement
• Ensure the cleanroom environment meets regulatory and operational requirements
• Collaborate with the quality unit to address deviations, audits, and investigations
• Assist in the development of new formulations and process enhancements
• Maintain inventory of compounded products in real time
• Train and mentor staff on best practices in sterile compounding
• Enforce company policies, procedures, and personnel management to maintain a positive work environment
• Drive process innovation and efficiency improvements in compounding workflows

Qualifications & Requirements

• PharmD or Bachelor of Science (B.S.) in Pharmacy
• Active Pharmacist License in New York (additional state licenses preferred)
• 2–5 years of experience managing or working closely with pharmacy technicians
• Deep understanding of FDA, USP <797>, <800>, and <795> guidelines
• Strong leadership, problem-solving, and team-building skills
• Excellent attention to detail and ability to maintain meticulous records
• Ability to adapt to new protocols, process improvements, and compliance updates