Hims & Hers is a health and wellness platform on a mission to help the world feel great through better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal. The Senior Manager, Sterile Operations will oversee sterile compounding and act as a subject matter expert in sterile compounding, ensuring strict compliance with USP 797, 800 and other applicable chapters.
Requirements
- 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
- Drive daily/weekly/monthly performance for Safety, Quality, and Financial performance metrics
- Maintain training requirements to support the execution of sterile compounding
- 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 the 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
Benefits
- Competitive salary & comprehensive health benefits including medical, dental & vision
