Description
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health.
The Manager, Sterile Operations, will be responsible for overseeing sterile compounding in their designated Modular Cleanroom Shift and acting as a subject matter expert in sterile compounding.
Responsibilities:
- Serve as one of the Designated Persons for USP 797 and USP 800 when assigned by leadership
- Maintain and enforce proper aseptic technique and cleanroom standards
- Provide training and supervision to compounding personnel
- Perform and accurately document compounding procedures, quality assurance/quality control checks, of compounded sterile preparations
- Review and approve materials prior to use in sterile compounding
- Oversee the use of equipment for sterile compounding operations and monitor the compounding environment in conjunction with the maintenance team
- Oversee cleanroom workflow, daily logs, and environmental monitoring procedures in conjunction with quality
- Supervise sterile compounding supervising pharmacists who are responsible for day-to-day compounding execution
- Work with R&D Teams on the development and scale-up of new compounded sterile preparations
- Follow all safety, USP, BOP, and internal guidelines for the preparation of compounded medications
- Maintain a safety-first mindset and ensure precautions are taken in all compounding activities in accordance with USP 797
- Wear all personal protective equipment (PPE) when required
- Coordinate with the Pharmacist-in-charge (PIC) for personnel, quality, compliance, and regulatory matters
- Complete external training as required
Requirements:
- 3+ years of pharmacy experience with sterile compounding exposure, preferably compounding from non-sterile starting components
- Doctor of Pharmacy (Pharm D), with 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 related to the practice of pharmacy
- 1+ years in a managerial role over Pharmacists, Technicians, and pharmacy support personnel
- Ability to work flexible shift times
- Proficiency in Windows-based computer systems
- Must be able to undergo respirator fit testing
- Must be a knowledgeable and empathetic leader to in-person pharmacist and technician teams
- Must be able to lift at least 25 pounds with or without reasonable accommodation
- Must be able to stand for long periods of time
Preferred Qualifications:
- 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
- 3+ years in a managerial role over Pharmacists, Technicians, and pharmacy support personnel
Benefits:
- Competitive salary & comprehensive health benefits including medical, dental & vision