Principal Sterilization Microbiologist

Job Title: Principal Sterilization Microbiologist
Location: Park Ridge, NJ area
Hours / Schedule: M-F, 8am - 5pm, Full Time
Type: Direct Hire

Responsibilities
As the Principal Sterilization Microbiologist, you will serve as the enterprise-wide technical expert and strategic lead in sterilization science, sterility assurance, and microbiological efficacy. This role is responsible for setting the technical direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through commercialization. This role will help enhance company position as an innovative and trusted partner in infection prevention and control.

• You will 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. Your expertise will directly impact product safety, regulatory success, and speed-to-market for critical medical devices and healthcare products. As a recognized authority, you will guide internal and external teams on the application of sterilization standards (e.g., ISO 11135, 11137, 11737, USP <71>, etc.), and represent the company in regulatory interactions, technical forums, and industry partnerships.
• This role demands 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. The Principal Scientist must demonstrate a high level of autonomy, demonstrating ownership, leadership, and coordination in driving projects to success while keeping leadership and the business updated on progress. A proactive approach in identifying opportunity areas, and a strong drive for results and organizational improvement are essential.
• Sterilization & Microbiological Expertise
• Lead development, optimization, and validation of sterilization processes including ethylene oxide, dry heat, gamma irradiation, and vaporized hydrogen peroxide
• Define and execute strategies for bioburden reduction, biological indicator selection, and sterilization dose mapping and auditing
• Serve as subject matter expert on ISO 11135, 11137, 11737, USP <71>, and related standards
• Provide technical leadership in method selection, packaging compatibility, and efficacy testing throughout the product lifecycle
• Assess and communicate technical risks and mitigation strategies to leadership and cross-functional teams
• Laboratory Leadership & Scientific Rigor
• Oversee microbiological method development, validation, and data interpretation for regulatory submissions
• Manage complex laboratory investigations and ensure scientific rigor across testing strategies
• Develop and maintain standard operating procedures (SOPs) and laboratory best practices
• Identify capability gaps and implement new technologies or infrastructure improvements
• Technical Project Ownership
• Own the end-to-end sterilization strategy and execution, ensuring alignment with product development timelines, regulatory requirements, and business goals
• Define project goals, align cross-functional teams, and secure resources to meet milestones
• Monitor progress, resolve challenges, and ensure delivery of high-quality outcomes
• Communicate updates and findings to senior leadership clearly and effectively
• Cross-Functional Collaboration
• Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements into project plans and quality systems
• Influence decision-making through technical insight and data-driven recommendations
• Provide technical leadership in the selection of sterilization methods, packaging compatibility assessments, and efficacy test strategies during new product introduction and product lifecycle management
• Innovation & Capability Building
• Drive implementation of new methods, technologies, and process improvements in microbiology and sterility assurance for both R&D and production environments
• Evaluate and adopt emerging technologies that strengthen internal capabilities
• Contribute to intellectual property development through patents and trade secrets.
• Mentorship & Knowledge Development
• Mentor and coach junior scientists, fostering technical growth and critical thinking
• Promote a culture of continuous improvement, collaboration, and scientific excellence
• Lead internal training on sterilization principles, regulatory standards, and laboratory practices

Requirements

• Degree in Biological Science, or related discipline, required
• Masters / Ph.D. an advantage
• Expert Microbiology and Sterilization understanding
• 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
• Identifies opportunities and takes risks to achieve objectives
• Simplify complex ideas, collaborate effectively, deliver results, and innovate in sterility assurance
• Able to work on multiple projects of varying complexity
• Ability to evolve, learn and implement new systems and programs
• Initiative taker, ambitious and 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.

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Ref: #558-Scientific