Principal Sterilization Microbiologist

DESCRIPTION

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

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 PDI's 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.

Essential Functions & Responsibilities

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. Core Competencies & Values:

• Accountability: Takes full ownership of sterilization strategy and execution, ensuring timely and compliant outcomes.
• Communication: Clearly conveys complex scientific concepts to technical and non-technical stakeholders.
• Collaboration: Builds strong partnerships across R&D, Quality, Regulatory, and Operations.
• Drive for Results: Demonstrates urgency and persistence in achieving project milestones and business goals.
• Decision Quality: Uses data-driven insights and scientific rigor to inform high-stakes decisions.
• Instills Trust: Acts with integrity, transparency, and consistency in all interactions.

PERFORMANCE MEASUREMENTS

• Ability to work in partnership with product development, operations, and regulatory functions.
• Communicate scientific findings clearly and make meaningful contributions to projects.
• Support work stream timelines and be able to balance priorities according to stakeholder needs.
• Able to communicate and cooperate with other team members and cross function teams effectively.
• Demonstrate ability to add value to the organization through scientific excellence.
• Take ownership for assigned projects and self-lead initiatives.
• Demonstrated success in validation and implementation of robust, compliant sterilization processes
• Timely and effective contributions to regulatory submissions, audits, and inspections
• Documented scientific leadership in internal and external forums (e.g., publications, conferences)
• Positive impact on project timelines and technical risk mitigation
• Leadership in mentoring, collaboration, and cross-functional engagement

QUALIFICATIONS:

EDUCATION/CERTIFICATION

• Degree in Biological Science, or related discipline, required
• Masters/Ph.D. an advantage

REQUIRED KNOWLEDGE

• 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.

EXPERIENCE REQUIRED

• 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
• Demonstrated experience leading cross-functional teams and driving key capability evaluations and sterile technology selection.

SKILLS/ABILITIES

• 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

WORKING CONDITIONS

• About 25% Lab and 75% office environment

SALARY RANGE:

• $135,000 - $165,000

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

• Medical, behavioral & prescription drug coverage
• Health Savings Account (HSA)
• Dental
• Vision
• 401(k) savings plan with company match and profit sharing
• Basic and supplemental Life and AD&D insurance
• Flexible Spending Accounts (FSAs)
• Short & long-term disability
• Employee Assistance Program (EAP)
• Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.