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Hims & Hers, a leading public health and wellness platform (NYSE: HIMS), is seeking a Manager of Sterile Operations to oversee sterile compounding activities in a designated Modular Cleanroom Shift. This role combines operational leadership with deep pharmaceutical expertise, ensuring compliance with USP 797 and 800 standards while managing a team of pharmacists and technicians.
Key Responsibilities:
- Oversee sterile compounding operations and serve as a subject matter expert in aseptic technique and cleanroom standards
- Provide training, supervision, and leadership to compounding personnel and supervising pharmacists
- Perform and document compounding procedures, quality assurance/quality control checks, and environmental monitoring
- Review and approve materials prior to use; oversee equipment maintenance and cleanroom workflow
- May serve as Designated Person for USP 797/800 compliance when assigned
- Coordinate with the Pharmacist-in-Charge on personnel, quality, compliance, and regulatory matters
- Work with R&D teams on development and scale-up of new compounded sterile preparations
- Maintain safety-first mindset, ensure proper PPE use, and comply with all USP, BOP, and internal guidelines
- Handle hazardous drugs in accordance with USP <800> and applicable laws
Physical Requirements:
- Ability to work flexible shift times, including up to 12-hour shifts
- Must be able to stand up to 100% of the time, walk up to 50%, squat/bend up to 20%, and lift up to 50 lbs up to 80% of the time
- Must pass respirator fit testing; full beards or significant facial hair may prevent proper seal
- Must be able to wear compounding safety equipment for extended periods
- Medical approval required to wear respiratory protection (N95, full face respirator, SCBA, or PAPR)
- Must confirm understanding of reproductive risks associated with handling hazardous drugs
Requirements:
- Doctor of Pharmacy (Pharm.D.) with active license in Ohio
- 3+ years of pharmacy experience including sterile compounding exposure, preferably from nonsterile starting components
- Certified Compounded Sterile Preparation Technician® (CSPT®) or willingness to complete within first year
- 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 supervising pharmacists, technicians, and pharmacy support personnel
- Proficiency in Windows-based computer systems
- Knowledgeable and empathetic leader for in-person teams
- Ability to maintain security and privacy rules regarding PHI in compliance with HIPAA
Preferred Qualifications:
- Board Certification in Sterile Compounding or willingness to complete within first year
- 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 (State Board, FDA, NABP)
- 3+ years in a managerial role over pharmacists, technicians, and support personnel
