Manager, Sterile Operations

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.​​About the Role:The Manager, Sterile Operations, will be responsible for the oversight of sterile compounding in their designated Modular Cleanroom Shift, as well as acting as a subject matter expert in sterile compounding. You will ensure strict compliance with USP 797, 800 (and other applicable chapters) in order to compound safe and effective sterile preparations in accordance with state and federal law. You Will:You may serve as one of the Designated Persons for USP 797 and USP 800 when assigned by your leadership.Maintain and enforce proper aseptic technique and cleanroom standardsProvide training and supervision to compounding personnelPerform and accurately document compounding procedures, quality assurance/quality control checks, of compounded sterile preparationsReview and approve materials prior to use in sterile compoundingOversee the use of equipment for sterile compounding operations and monitor the compounding environment in conjunction with the maintenance teamOversee cleanroom workflow, daily logs, and environmental monitoring procedures in conjunction with qualitySupervise sterile compounding supervising pharmacists who are responsible for day-to-day compounding executionWork with R&D Teams on the development and scale-up of new compounded sterile preparationsFollow all safety, USP, BOP, and internal guidelines for the preparation of compounded medicationsMaintain a safety-first mindset and ensure precautions are taken in all compounding activities in accordance with USP 797, including when working with hazardous chemicals in accordance with USP <800> and applicable lawsWhen required, wear all personal protective equipment (PPE)Coordinate with the Pharmacist-in-charge (PIC) for personnel, quality, compliance, and regulatory mattersWillingness to complete external training as requiredYou Have:3+ years of pharmacy experience that includes sterile compounding exposure, preferably compounding from nonsterile 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 pharmacy1+ years in a managerial role over Pharmacists, Technicians, and pharmacy support personnel.Ability to work flexible shift timesProficiency in Windows-based computer systemsMust be able to undergo respirator fit testing - Full beards or a lot of facial hair may prevent a proper seal for the respiratorMust be a knowledgeable and empathetic leader to in-person pharmacist and technician teamsMust be able to lift at least 25 pounds with or without reasonable accommodationMust be able to stand for long periods of timePharmacists will work in a variety of positions and locations, such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of timeMust be able to wear required compounding safety equipment for long periods of ... (truncated, view full listing at source)