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Hims & Hers, a leading public health and wellness platform (NYSE: HIMS), is seeking a Manager of Sterile Operations for night shift work at their New Albany, Ohio facility. This role oversees sterile compounding operations in a modular cleanroom environment, ensuring strict compliance with USP 797 and USP 800 standards for safe, effective sterile medication preparation.
Key responsibilities include supervising sterile compounding pharmacists and technicians, maintaining aseptic technique and cleanroom standards, performing and documenting compounding procedures and quality assurance checks, reviewing materials prior to use, overseeing equipment and environmental monitoring, and coordinating with the Pharmacist-in-Charge on personnel, quality, compliance, and regulatory matters. You will serve as a subject matter expert in sterile compounding, potentially acting as a Designated Person for USP 797/800 compliance, and collaborate with R&D teams on development and scale-up of new compounded sterile preparations. The role requires strict adherence to safety protocols, USP guidelines, state and federal pharmacy laws, and HIPAA regulations when handling protected health information.
Required qualifications: Doctor of Pharmacy (Pharm D) with active Ohio license, 3+ years pharmacy experience including sterile compounding exposure (preferably from nonsterile starting components), 1+ years in a managerial role supervising pharmacists and technicians, CSPT® certification or willingness to obtain within first year, deep knowledge of USP 797/800, awareness of state/federal pharmacy regulations, ability to work flexible shifts, Windows proficiency, and physical capability to lift 25+ pounds and stand for extended periods. Medical clearance for respirator use is required; full beards or significant facial hair may prevent proper respirator seal. Preferred qualifications include Board Certification in Sterile Compounding, Designated Person or Assigned Trainer status, experience with regulatory inspections, and familiarity with electronic documentation and compounding workflow software.
The position involves working with hazardous drugs and requires wearing comprehensive personal protective equipment including gloves, respiratory protection, gowns, and other items as needed. Physical demands include walking up to 50% of the time and prolonged standing.
