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About The Role:
- Lead all phases of new product introduction (NPI) for all sterile compounded products, ensuring compliance with 503A & 503B regulations and quality standards.
- Work closely with PMO PMs and SME PMs to ensure key deliverables are executed in time for launch.
- Develop and optimize NPI processes for a growing business.
R&D and Analytical Development Coordination:
- Oversee due diligence, formula development, and R&D.
- Align with formulation scientists and analytical chemists on method development and sample testing.
- Ensure timely execution of formulation, method development, process development, tech transfer, and equipment validation activities.
Quality Partnership:
- Work closely with our Quality team & Quality PMs to ensure proper alignment and execution is followed throughout the project.
- Document risks and mitigation plans to align with necessary USP and cGMP compliance standards.
- Support regulatory submission preparation and documentation.
Hims & Hers
Hims & Hers is a health and wellness platform committed to making people feel great through better health by delivering affordable and personalized care. They are a public company traded on the NYSE under the ticker symbol “HIMS” with a talent-first flexible/remote work approach.