Manager, Sterile Operations (Night Shift)
Hims & Hers· PHARMACY
New Albany, OhioFull-timePosted 11mo ago
About the role
Manager overseeing sterile compounding in a Modular Cleanroom, ensuring compliance with USP 797/800 and applicable regulations; responsible for training, supervision, and operations of sterile preparation to support R&D and production of compounded sterile medications.
Responsibilities
- Serve as Designated Person for USP 797/800 when assigned by leadership
- Maintain and enforce proper aseptic technique and cleanroom standards
- Provide training and supervision to compounding personnel
- Perform and document compounding procedures and QA/QC checks of compounded sterile preparations
- Review and approve materials prior to use in sterile compounding
- Oversee equipment use and monitor the compounding environment with maintenance team
- Oversee cleanroom workflow, daily logs, and environmental monitoring with quality
- Supervise sterile compounding supervising pharmacists responsible for day-to-day execution
- Collaborate with R&D on development and scale-up of new compounded sterile preparations
- Follow safety, USP, BOP, and internal guidelines for compounded medications
- Maintain a safety-first mindset and ensure precautions for USP 797 and USP <800> compliance with hazardous chemicals
- Wear PPE as required
- Coordinate with Pharmacist-in-charge (PIC) on personnel, quality, compliance, and regulatory matters
- Willingness to complete external training as required
Qualifications
- 3+ years of pharmacy experience with sterile compounding exposure
- Doctor of Pharmacy (Pharm D) with active Ohio license
- Certified Compounded Sterile Preparation Technician® (CSPT®) or willingness to complete in first year
- Deep knowledge of USP 797 and 800 requirements and best practices
- Awareness of state and federal pharmacy laws and regulations
- 1+ year in a managerial role over Pharmacists, Technicians, and support personnel
- Ability to work flexible shift times
- Proficiency in Windows-based computer systems
- Ability to undergo respirator fit testing; facial hair may affect seal
- Empathetic leadership for in-person pharmacist and technician teams
- Ability to lift at least 25 pounds and stand for long periods
- Flexibility to work in various positions (sitting, standing, squatting, kneeling, etc.) for prolonged periods
- Ability to wear compounding safety equipment for extended periods
- Maintain PHI security and comply with HIPAA
- Follow state Board of Pharmacy and FDA regulations
- Maintain a clean and sanitary work environment per FDA rules
Skills
Required:Sterile compounding
Benefits
- Competitive salary & comprehensive health benefits including medical, dental & vision
Last updated Sep 2, 2026. Interested? Apply on the company site.
About Hims & Hers
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