Sterile Operations Manager: Lead Compounding

Hims; New Albany (OH); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive salary

Health benefits (medical, dental, &amp

Job summary

Hims is seeking a Manager, Sterile Operations to oversee sterile compounding in a Modular Cleanroom and ensure USP 797/800 compliance. You will train personnel, document procedures, and supervise pharmacists and technicians while coordinating with the PIC on regulatory matters.

You will lead aseptic technique, supervise workflow, and work with R&D on scale-up of new sterile products, maintaining safety and privacy per HIPAA and FDA guidelines.

Qualifications

• 3+ years of pharmacy experience with sterile compounding exposure.
• Pharm D with Ohio license active.
• CSPT or willingness to complete in first year.
• Deep knowledge of USP 797 and 800 requirements.
• Awareness of state and federal pharmacy laws and regs.
• 1+ year in a managerial role over pharmacists and technicians.
• Ability to work flexible shift times.
• Proficiency in Windows-based systems.

Responsibilities

• Oversee sterile compounding in the designated Modular Cleanroom shift.
• Serve as a Designated Person for USP 797/800 when assigned.
• Provide training and supervision to compounding staff.
• Document compounding procedures and QC checks.
• Review materials prior to use in sterile compounding.
• Monitor equipment and cleanroom environment with maintenance/QA.
• Supervise sterile compounding supervising pharmacists.
• Collaborate with R&D on scale-up of new preparations.
• Maintain safety, USP, BOP, and internal guidelines.
• Ensure PPE use and HIPAA privacy compliance.

Skills

Sterile compounding

Pharmacist leadership

USP 797/800 knowledge

Regulatory compliance

PHI handling

Respirator fit testing

Team supervision

Education

Pharm D

Tools

Electronic documentation systems

Compounding workflow software

Job description

Hims is seeking a Manager, Sterile Operations to oversee sterile compounding in a Modular Cleanroom and ensure USP 797/800 compliance. You will train personnel, document procedures, and supervise pharmacists and technicians while coordinating with the PIC on regulatory matters.

You will lead aseptic technique, supervise workflow, and work with R&D on scale-up of new sterile products, maintaining safety and privacy per HIPAA and FDA guidelines.