Principal Sterilization Microbiologist

Principal Sterilization Microbiologist

Join our team as a Principal Sterilization Microbiologist in the Park Ridge, NJ area. This full-time position offers an opportunity to serve as the enterprise-wide technical expert and strategic lead in sterilization science, sterility assurance, and microbiological efficacy.

Job Description

• Serve as the enterprise-wide technical expert and strategic lead in sterilization science, sterility assurance, and microbiological efficacy.
• Set the technical direction, lead high-impact sterilization programs, and ensure full regulatory compliance across the product lifecycle—from development through commercialization.
• Enhance the company's position as an innovative and trusted partner in infection prevention and control.
• Lead the strategic direction of sterilization efforts, including setting long-term goals, evaluating and recommending sterilization technologies, assessing risks and success likelihood, and conducting hands-on testing when necessary.
• Guide internal and external teams on the application of sterilization standards (e.g., ISO 11135, 11137, 11737, USP, etc.) and represent the company in regulatory interactions, technical forums, and industry partnerships.
• Demonstrate excellence in scientific judgment, cross-functional collaboration, and the ability to mentor others while setting long-term technical strategies aligned with corporate innovation and compliance goals.
• Demonstrate a high level of autonomy, ownership, leadership, and coordination in driving projects to success while keeping leadership and the business updated on progress.
• Identify opportunity areas proactively and drive results and organizational improvement.

Requirements

• Degree in Biological Science or related discipline required; Masters/Ph.D. is an advantage.
• Expert understanding of microbiology and sterilization.
• Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC.
• Strong knowledge of QbD principles and designing appropriate DOE studies to inform on risks.
• 8-10 years' experience in microbiology for regulated products; 5+ years of direct sterilization experience.
• Deep drug product development expertise with exposure to all stages and aspects of development (preclinical, clinical, and commercial) and cGMP industrial background.
• Excellent communication skills (verbal/written); ability to explain science to management.
• Ability to identify opportunities and take risks to achieve objectives.
• Ability to simplify complex ideas, collaborate effectively, deliver results, and innovate in sterility assurance.
• Ability to work on multiple projects of varying complexity.
• Initiative taker, ambitious, driven, resourceful, and able to find creative and innovative ways to achieve results.
• Computer literate (Outlook/Word/Excel, M365).

Benefits

As this is a direct hire position with our client, System One benefits described below would not apply to this role. Benefits program with the client would be those applicable to this role.