Senior Sterilization Microbiologist

Title:  Senior Sterilization Microbiologist
Location: Park Ridge, NJ area
Schedule:  M-F Full Time
Type:  Direct Hire

Responsibilities:
This role is part of the R&D Microbiology team and involves leading the application and interpretation of standards and regulations related to 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 current portfolio to provide a competitive edge in a challenging marketplace.

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.

Requirements:

• University Degree in a Biological Science required (Masters/Ph.D. an advantage)
• Previous experience in a regulated R&D environment supporting Product Development.
• Strong Microbiology understanding.
• Working knowledge of FDA regulations a plus.
• 5 years' experience in sterilization or microbiology for regulated products.
• Responsible for ensuring compliance with standards governing Ethylene Oxide, Dry Heat, X-Ray or Gamma sterilization.

Ref: #558-Scientific