Sterile Operations Manager: GMP & USP 797/800 Expert

hims-and-hers; Beloit (OH); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive salary

Health benefits

Job summary

Hims & Hers is seeking a Manager of Sterile Operations to oversee sterile compounding in a Modular Cleanroom, ensuring USP 797/800 compliance and adherence to state and federal laws.

You will train and supervise compounding personnel, review materials, and coordinate with the Pharmacist-in-charge on compliance and quality matters. This role requires a Pharm D and Ohio license, with CSPT certification preferred.

Qualifications

• 3+ years of pharmacy experience including sterile compounding exposure.
• Pharm D with active Ohio license.
• CSPT or willingness to obtain in first year.
• Strong knowledge of USP 797/800 and related regulations.
• Experience managing pharmacists, technicians and support staff.

Responsibilities

• Oversee sterile compounding in designated cleanroom, ensuring USP standards.
• Serve as a Desig­nated Person for USP 797/800 when assigned.
• Train and supervise compounding personnel; document procedures.
• Review materials and oversee equipment and environmental monitoring.
• Coordinate with PIC on personnel, quality, and regulatory matters.
• Support R&D on new sterile preparations and scale-up.

Skills

Sterile compounding

Pharmacy management

USP 797/800

Regulatory compliance

Leadership

Education

Pharm D

OH pharmacist license

Tools

Windows OS

Job description

Hims & Hers is seeking a Manager of Sterile Operations to oversee sterile compounding in a Modular Cleanroom, ensuring USP 797/800 compliance and adherence to state and federal laws.

You will train and supervise compounding personnel, review materials, and coordinate with the Pharmacist-in-charge on compliance and quality matters. This role requires a Pharm D and Ohio license, with CSPT certification preferred.