Manager, Sterile Operations

hims & hers
United States
Workplace: OnsiteFull timeFunction: Laboratory & Clinical OperationsExperience: 3+ yearsEducation: professionalSkills: ["Leadership","Training","Supervision","Compliance focus","Attention to detail"]

Oversee sterile compounding within a modular cleanroom shift and serve as a sterile-compounding subject matter expert. Ensure USP 797/800 and other applicable compliance for safe, effective sterile preparations in accordance with state and federal law. Supervise compounding pharmacists, maintain aseptic technique and cleanroom standards, train and support personnel, review and approve materials, and coordinate environmental monitoring and quality checks. Partner with R&D on new sterile preparation scale-up.

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FursaFursa
hims & hers
hims & hers
2 days ago

Manager, Sterile Operations

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Source: Company careers pageValidated by: Fursa AI
Last checked: 21 hours agoStatus: Live

Job Summary

Oversee sterile compounding within a modular cleanroom shift and serve as a sterile-compounding subject matter expert. Ensure USP 797/800 and other applicable compliance for safe, effective sterile preparations in accordance with state and federal law. Supervise compounding pharmacists, maintain aseptic technique and cleanroom standards, train and support personnel, review and approve materials, and coordinate environmental monitoring and quality checks. Partner with R&D on new sterile preparation scale-up.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Laboratory & Clinical Operations
Seniority: Manager level

Key Responsibilities

  • •Oversee sterile compounding operations in the designated Modular Cleanroom Shift and act as a subject matter expert in sterile compounding.
  • •Ensure compliance with USP 797/800 and applicable state and federal requirements for safe, effective sterile preparations.
  • •Maintain and enforce aseptic technique and cleanroom standards, including environmental monitoring, daily logs, and cleanroom workflow.
  • •Provide training and supervision to compounding personnel and supervise sterile compounding supervising pharmacists responsible for day-to-day execution.
  • •Review and approve compounding materials prior to use and coordinate with the Pharmacist-in-charge (PIC) on personnel, quality, compliance, and regulatory matters.

Pay and Benefits

Perks:Health InsuranceDentalVisionMedical

Key Requirements

  • •3+ years of pharmacy experience with sterile compounding exposure, preferably compounding from nonsterile starting components.
  • •Doctor of Pharmacy (Pharm D) with an 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 USP 800 requirements and best practices.
  • •1+ years in a managerial role over pharmacists, technicians, and pharmacy support personnel.
Experience:3+ yearsPharmacyHealthcareSterile compounding
Education:Professional (JD, MD, etc.)
Skills:LeadershipTrainingSupervisionCompliance focusAttention to detail
Licenses:Active Pharmacy License (State of Ohio)
Certifications:Certified Compounded Sterile Preparation Technician (CSPT)
Tech Stack:Windows-based computer systems

Company Brief

hims & hers
A telehealth and consumer wellness platform offering personalized care and products across sexual health, hair, mental health, dermatology, weight loss and primary care via digital consultations, prescriptions, and fulfillment.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Francisco, United States
Founded: 2017
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