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