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Lake Forest, IL 60045
The Biocompatibility Specialist will report to the Manager Biocompatibility-Microbiology, in the Device Quality group. The responsibilities for this position span the product portfolio of consumable medical devices, IV Solutions (Large Volume Parenterals), and support for the duration of the Pfizer Technical Services Agreement for combination products. The Biocompatibility Specialist will be responsible for Biocompatibility, Extractable & Leachable (E&L) and Microbiological Testing activities, which includes classification of the product category, interpretation of the applicable regulatory guidance and standards for each product category and developing a robust Biocompatibility, E&L and Microbiological test panel to ensure compliance with national and international regulatory requirements. Additionally, the Biocompatibility Specialist shall work as a liaison between contract research labs and ICU Medical and shall co-ordinate testing, assessing test data and writing/reviewing biocompatibility, E&L assessments, summary reports for regulatory submission package. In the short term, this individual will support the Biocompatibility, E&L and Microbiological test requirements (including Bacterial Endotoxin and product particulate testing).
Other responsibilities include working closely with Core team leader in understanding the stakeholder needs and collaborating with cross-functional team members in understanding test sample/ corner case selection criteria for products/ product families to be tested in order to increase efficiency in testing. Responsibilities also include staying up-to date-with changes to applicable international standards and regulations that apply to medical devices and IV Solutions (Large Volume Parenterals) and participate in development of standards. This position is responsible for coordinating and following procedures and protocols at ICU Medical that are pertaining to biocompatibility and microbiology.
Essential Duties & Responsibilities
• Coordinate biological and chemical clearance for use studies for new and modified devices and parenteral drug products and related manufacturing processing aids
• Act as liaison between ICU Medical design engineers and contract test laboratories conducting Biocompatibility tests
• Generate verification protocols, verification summary reports in support of Biocompatibility projects.
• Aid in development of internal policies and procedures regarding biosafety compliance requirements
• Develop Biocompatibility/ E&L test panels based on applicable Regulatory and International standards for compliance.
• Act as ICU Medical Representative to Industry Biosafety/Biocompatibility-related standard committees
• Working closely with Core team leader in understanding the project needs and collaborating with cross-functional team members to appropriately establish test sample/ corner case selection criteria for products/ product families to be tested in order to increase efficiency in testing.
• Support and execute audits of contract laboratories
• Perform material searches in various databases for historical biocompatibility studies
• Support responses to Customer queries on biocompatibility issues
• Support responses to Regulatory queries for historical biocompatibility reports to support International Registrations
• Perform/coordinate biological and chemical testing in response to Marketing and customer requirements and in light of adverse patient reports
• Ensure that the appropriate external biocompatibility testing laboratories are qualified to support internal testing volumes and projects.
Knowledge, Skills & Qualifications
• Knowledge of chemistry and/or biology, basic understanding of medical device manufacturing processes, large volume parenteral manufacturing processes, and sterilization methods and their effects on the biocompatibility of polymeric biomaterials used in the medical applications. Ability to interpret medical device and/or pharmaceutical material biosafety standards and create Biocompatibility test panels for internal customers. Ability to multi-task and coordinate competing priorities.
Education and Experience
• Bachelor’s degree in Life Sciences (Biology, Chemistry, or Materials Science) or a closely related scientific discipline.
• 3 years of experience required, 5 years of experience preferred
• Must be at least 18 years of age
• Must pass pre-employment drug screen and background check
• Typically requires travel less than 5% of the time
Physical Requirements and Work Environment
• This job operates in a professional office environment and routinely uses standard office equipment.
• Must be able to occasionally move and lift objects of up to 25 lbs. – carrying boxes of test samples for shipping to the contract labs.
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.
Title: Specialist, Biocompatibility
Location: IL-Lake Forest
Requisition ID: 19300107