Director, Sterile Product Sterility Assurance

Role Overview

The Director, Sterile Product Sterility Assurance will serve as a technical leadership position with a strong focus on sterilization science and sterility assurance across drug products, primary containers, devices, and combination products. The role will influence development strategy, regulatory approaches, and manufacturing readiness for sterile products.

What You Will Do

The successful candidate will provide technical leadership for sterilization strategy, sterility assurance, and contamination control for sterile drug products. They will define, evaluate, and implement sterilization strategies across development stages, including moist heat, vaporized hydrogen peroxide, and alternative low-temperature technologies.

Why It Might Be a Fit

The ideal candidate will have demonstrated hands-on and strategic experience in sterilization science, including sterilization cycle development and validation, sterility assurance, microbiology, and environmental monitoring. They will have a strong understanding of sterilization technologies for pharmaceutical products, medical devices, and combination products.

Requirements

- Ph.D. with 8+ years industry experience, or M.S. with 10+ years, or B.S. with 12+ years in Chemical Engineering, Biochemical Engineering, Pharmaceutics, Pharmaceutical Sciences, Microbiology, Chemistry, Biochemistry, or a related discipline - Demonstrated hands-on and strategic experience in sterilization science, including sterilization cycle development and validation, sterility assurance, microbiology, and environmental monitoring - Strong understanding of sterilization technologies for pharmaceutical products, medical devices, and combination products, including risk-based selection of terminal vs. aseptic approaches - Experience applying Quality by Design (QbD) principles and DOE methodologies to formulation, process, and sterilization development - Proven experience with process scale-up, validation, and technology transfer, including collaboration with manufacturing sites and equipment vendors - Working knowledge of FDA, ICH, and global regulatory expectations related to sterilization, aseptic processing, and CMC - Demonstrated scientific leadership, strong communication skills, and a track record of mentoring and developing junior scientists Benefits

- Medical, dental, vision healthcare and other insurance benefits (for employee and family) - Retirement benefits, including 401(k) - Paid holidays, vacation, and compassionate and sick days

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