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Manager, Sterile Operations

Hims & Hers· PHARMACY
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New Albany, OhioFull-timePosted 4w ago

About the role

Manager responsible for oversight of sterile compounding in the Modular Cleanroom, ensuring compliance with USP 797/800 and related regulations, and leading sterile operations teams in Hims & Hers’ Pharmacy department.

Responsibilities

  • Serve as Designated Person for USP 797/800 when assigned
  • Maintain and enforce proper aseptic technique and cleanroom standards
  • Provide training and supervision to compounding personnel
  • Perform and document compounding procedures, QA/QC checks of compounded sterile preparations
  • Review and approve materials prior to use in sterile compounding
  • Oversee equipment use for sterile compounding and monitor environment with maintenance
  • 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 safety-first mindset and compliance with USP 797/800 and applicable laws (hazardous drugs)
  • Wear PPE as required
  • Coordinate with Pharmacist-in-Charge on personnel, quality, compliance, and regulatory matters
  • Willingness to complete external training as required

Qualifications

  • 3+ years of pharmacy experience including sterile compounding exposure (preferably from non-sterile starting components)
  • Doctor of Pharmacy (Pharm D), active Ohio license
  • 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 over Pharmacists, Technicians, and pharmacy 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)
  • Knowledgeable and empathetic leader to in-person pharmacist and technician teams
  • Ability to lift at least 25 pounds and stand for long periods
  • Ability to work in varied positions (sitting, standing, squatting, kneeling, reaching, walking) for prolonged periods
  • Ability to wear required compounding safety equipment for long periods
  • Maintain PHI security and privacy per HIPAA and laws
  • Follow state Board of Pharmacy and FDA regulations
  • Maintain clean and sanitary work environment per FDA rules

Skills

Required:Sterile compoundingRegulatory compliance (USP 797/800, BOP, FDA)Leadership/people management

Benefits

  • Competitive salary & comprehensive health benefits including medical, dental & vision
Last updated Sep 30, 2026. Interested? Apply on the company site.

About Hims & Hers

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