Manager, Sterile Operations

The role

The Manager, Sterile Operations oversees sterile compounding in a designated Modular Cleanroom Shift. You will act as a subject matter expert to ensure compliance with USP 797, 800, and other applicable laws.

What you will do

• Maintain and enforce proper aseptic technique and cleanroom standards
• Provide training and supervision to compounding personnel
• Perform and accurately document compounding procedures and quality assurance checks
• Review and approve materials prior to use in sterile compounding
• Oversee the use of equipment and monitor the compounding environment
• Oversee cleanroom workflow, daily logs, and environmental monitoring procedures
• Supervise sterile compounding supervising pharmacists
• Work with R&D Teams on the development and scale-up of new compounded sterile preparations
• Follow all safety, USP, BOP, and internal guidelines
• Coordinate with the Pharmacist-in-charge for personnel, quality, compliance, and regulatory matters

Required qualifications

• 3+ years of pharmacy experience that includes sterile compounding exposure
• Doctor of Pharmacy (Pharm D)
• Active license in the State of Ohio
• Certified Compounded Sterile Preparation Technician® (CSPT®) or willingness to complete in the first year of employment
• Deep working knowledge of USP 797 and 800 requirements and best practices
• Awareness of state and federal pharmacy laws, rules, and regulations
• 1+ years in a managerial role over Pharmacists, Technicians, and pharmacy support personnel
• Proficiency in Windows-based computer systems
• Must be able to undergo respirator fit testing
• Must be able to lift at least 25 pounds with or without reasonable accommodation
• Must be able to stand for long periods of time
• Must be able to wear required compounding safety equipment for long periods of time

Nice to have

• Board Certification in Sterile Compounding or willingness to complete in the first year of employment
• Designated Person or Assigned Trainer in sterile compounding pharmacy
• Experience compounding from non-sterile starting components
• Familiarity with electronic documentation systems and compounding workflow software
• Experience with regulatory inspections (e.g., State Board, FDA, NABP)
• 3+ years in a managerial role over Pharmacists, Technicians, and pharmacy support personnel

Benefits

• Competitive salary
• Comprehensive health benefits including medical, dental & vision

Before you apply

• Requires working with Hazardous Drugs (HD) and wearing Personal Protective Equipment (PPE)
• Requires medical approval to wear respiratory protection
• Must be willing to confirm understanding of potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs

About the company

Hims & Hers is a health and wellness platform that provides access to affordable, accessible, and personal healthcare. It is a public company traded on the NYSE.