Senior 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 Senior Manager, Sterile Operations will be responsible for the oversight of sterile compounding in their designated Modular Cleanroom Suite, 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:

• Serve as one of the Designated Persons for USP 797 and USP 800.

• Maintain and enforce proper aseptic technique and cleanroom standards

• Provide training and supervision to compounding personnel including direct supervision of 8 shift managers and indirect supervision of 100+ pharmacy technicians and pharmacists.

• Drive daily/weekly/month performance for Safety, Quality and Financial performance metrics

• Maintain training requirements to support the execution of sterile compounding including hand hygiene, gowning and media fill qualifications.

• Perform and accurately document compounding procedures, quality assurance/quality control checks, of compounded sterile preparations

• Review and approve materials prior to use in sterile compounding

• Oversee use of equipment for sterile compounding operations and monitor the compliant operation of the compounding environment in conjunction with the maintenance team

• Oversee cleanroom workflow, daily logs and environmental monitoring procedures in conjunction with quality

• Work closely with R&D Teams on the development and scale up of new compounded sterile preparations

• Work closely with the Technical Services team to create and implement projects that result in cost savings and process improvements that elevate quality standards and throughput capabilities.

• Partner with quality to perform risk assessments, conduct investigations, and design and implement remediation and risk mitigation strategies

• Follow all safety, USP, BOP, and internal guidelines for the preparation of compounded medications

• Maintain 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 laws

• When required, wear all personal protective equipment (PPE)

• Coordinate with the Pharmacist-in-charge (PIC) for personnel, quality, compliance and regulatory matters

• Willingness to complete external training as required

You Have:

• 5+ years of pharmacist experience, at least 3+ sterile compounding preferably compounding from nonsterile starting components.

• Board Certification in Sterile Compounding or willingness to complete in the first year of employment.

• Doctor of Pharmacy (Pharm D) or Bachelor’s degree in Pharmacy from an accredited institution.

• Active Pharmacist License in State of employment (AZ)

• Proficiency in USP 797 and 800 requirements and best practices.

• Current knowledge of state and federal pharmacy laws, rules and regulations related to the practice of pharmacy

• 3+ years in a managerial role over Pharmacists, Technicians, and pharmacy support personnel.

• Ability to work flexible shift times

• Proficiency in Windows based computer systems

• Must be able to undergo respirator fit testing - Full beards or a lot of fa