Sr 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

This role is part of the R&D Microbiology team and involves leading the application and interpretation of standards and regulations related to PDI's microbiological and sterility assurance control programs. Key responsibilities include analyzing data, developing tactical plans, implementing procedures, and leading remediation projects. Additionally, you'll conduct scientific research to support PDI's growth strategies, ensuring that our products meet stringent microbiological and sterility standards.

The position is a key component of scientific advancement in skin antiseptics and medical device sterilization. Primarily, the role supports new market launches with input across all facets of project progression including scientific insights, prototype assessment and registration testing to meet regulatory requirements. This position requires strong cross-functional collaboration and communication. In addition, developing equity building studies that enhance PDI's current portfolio to provide a competitive edge in a challenging marketplace.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

RESEARCH & DEVELOPMENT:

• Act as a sterilization and microbiology subject matter expert (SME), by supporting new product development, changes to existing commercial products.
• Guide product development teams with scheduling, budget estimates, deliverables, as needed to ensure project and product launch success, and compliance with applicable regulations, industry standards.
• Develop innovative microbiology solutions to support product development and meet regulatory requirements.
• Provide technical solutions to product development and engineering teams using various fields of science and sterilization theory and practice.
• Lead cycle development, validation, requalification activities, as well as product-specific sterilization qualifications and adoptions.

LABORATORY SUPPORT:

• Analyze samples, ensure compliance, and prepare, sterilize, and evaluate products with precision.
• Optimize laboratory space to ensure an efficient flow of work.
• Develop and refine methods, utilizing various techniques and instrumentation for accurate results
• Create new SOPs where gaps exist. Maintain SOP version revisions for continuous improvement initiatives.
• Maintain detailed records and partner with teams to ensure compliance and efficiency.

CROSS-FUNCTIONAL SUPPORT:

• Lead formulators to determine the correct method and dosage for sterile products
• Work with packaging and operations to ensure appropriate sterility assurance level
• Identify technical and project risks.
• Drive quick problem-solving, manage risks, and align teams on project goals.
• Prepare technical reports and technical presentations for internal meetings.
• Provide input to regulatory strategies as it relates to sterilization validation and verification

PERFORMANCE MEASUREMENTS

• Ability to work in partnership with the product development 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.

QUALIFICATIONS

EDUCATION/CERTIFICATION

• University Degree in a Biological Science required
• Masters/Ph.D. an advantage

REQUIRED KNOWLEDGE

• Previous experience in a regulated R&D environment supporting Sterile Products.
• Strong Microbiology understanding.
• Working knowledge of FDA regulations

EXPERIENCE REQUIRED

• 5+ years' experience in sterilization or microbiology for regulated products
• Responsible for ensuring compliance with standards governing Ethylene Oxide, Dry Heat, X-Ray and Gamma sterilization
• Experience in working in GxP laboratory facilities.

SKILLS/ABILITIES

• Excellent communication skills (verbal / written). Ability to explain science to management.
• Prudent risk taker. 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.
• Computer literate (Outlook / Word / Excel).

SALARY RANGE

• $65,000 - $90,000 annually

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.