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Senior Program Manager, Sterile NPI - Remote

Posted 2 days ago
Project Management
Full Time
USA

Overview

Hims & Hers is seeking a highly driven Senior Program Manager, Sterile NPI to lead the end-to-end product development and launch processes for sterile pharmaceutical products. The ideal candidate will have deep experience in regulated environments and a strong understanding of sterile manufacturing.

In Short

  • Lead cross-functional project teams through the full product development lifecycle.
  • Manage teams remotely and on-site.
  • Drive projects from concept through R&D to launch.
  • Prepare and present program updates to leadership.
  • Ensure compliance with 503A & 503B regulations.
  • Track budgets and resource allocation.
  • Collaborate with various departments for project execution.
  • Support regulatory submission preparation and documentation.
  • Conduct post-launch reviews and continuous improvement loops.
  • Foster a culture of continuous improvement.

Requirements

  • Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field.
  • 7+ years of project management experience in pharmaceutical or biotech product development.
  • Strong knowledge of 503A/503B regulatory frameworks.
  • Exceptional organizational, leadership, and communication skills.
  • PMP or similar project management certification preferred.
  • Experience with compounding pharmacies or CDMOs.
  • Familiarity with USP <797>, <800>, <795>, and cGMP standards.
  • Comfortable operating in a fast-paced environment.

Benefits

  • Competitive salary & equity compensation.
  • Unlimited PTO and company holidays.
  • Comprehensive health benefits including medical, dental & vision.
  • Employee Stock Purchase Program (ESPP).
  • 401k benefits with employer matching.
  • Offsite team retreats.
Hims & Hers logo

Hims & Hers

Hims & Hers Health, Inc. is a leading health and wellness platform dedicated to enhancing the well-being of individuals through innovative telehealth solutions. The company focuses on making personalized health products and services accessible, offering a range of nonprescription and prescription solutions for various health conditions, including mental health, sexual health, hair care, skincare, and heart health. As a publicly traded company on the NYSE under the ticker symbol 'HIMS', Hims & Hers is committed to continuous innovation in the healthcare space, promoting a culture that values flexibility, inclusivity, and exceptional patient care.

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