Principal Toxicology Scientist

• Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality
• Bachelor’s degree in Toxicology, Biology, Chemistry, or related science.

• 7+ years of experience with a Bachelor’s or 5+ years experience with an advanced degree conducting toxicological risk assessments, designing and performing toxicological assays, and/or overseeing biological safety assessments.

• In-depth knowledge of human physiology, biochemistry, and organ systems toxicology.
  • Must understand biological responses to foreign materials in the human body, including absorption, distribution, metabolism, and excretion (toxicokinetics), particle-mediated toxicity, as well as the foreign body response.  
• Knowledge of applicable ASTM, ISO, FDA, and EN standards as well as regulatory policies/guidance documents. 
  • An in-depth understanding of ISO 10993 biocompatibility standards; knowledge of ISO 18652 and 22442 standards. 
  • Knowledge of pertinent sections of REACH, the EU MDD/EU MDR, and Proposition 65 (hazardous substances regulations) as well as ICH and FDA Guidance Documents (e.g., Threshold of Toxicological Concern and Use of ISO 10993-1).
• Proficiency in conducting quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations. 
  • Knowledge of the risk assessment paradigm (i.e., hazard identification, exposure assessment, dose-response assessment, and risk characterization).
  • Self-sufficient in conducting scientific literature searches, extracting toxicity data, deriving tolerable exposure limits, as well as calculating margins-of-safety, hazard quotients, and hazard indices.

PREFERRED QUALIFICATIONS:

• PhD degree in Toxicology or related discipline preferred.
• Expertise in advanced scientific principles involving risk assessment, biochemical toxicology, organ systems toxicology, pharmacology and physiology, cell and molecular biology, immunotoxicology, reproductive and developmental toxicology, genotoxicity and carcinogenesis, neurotoxicity, pulmonary toxicity, gene-environment interactions, and biostatistics.
• Extensive publication and oral presentation record preferred with peer-reviewed publications and nationally recognized presentations.  
• Strong multitasking and organizational skills.
  • Proficient at scheduling and coordinating events, delegating and managing team responsibilities, prioritizing and executing assignments, establishing and meeting deadlines, as well as leading and maintaining productivity in a team environment. 
• Strong problem solving and analytical skills.
  • An independent creative/critical thinker with strategic planning/foresight and decision making abilities.
• Able to apply new scientific technology and approaches.
  • Involved in continuous education that is incorporated into the work environment. Willing to continuously improve processes for assessing the biocompatibility of medical devices.
• Excellent written communication and oral presentation skills.
  • Exhibits an outgoing character and ability to tailor communication to specific audiences by making complex ideas and projects understandable while maintaining a connection to the big picture. 
• Able to function independently as well as in a team environment.
  • Functions as an influential team member capable of motivating others in a cross-functional team environment to achieve project goals.  Teaches and educates colleagues to improve their skill set and productivity within a corporate setting.
• Computer proficiency with product lifecycle management, word processing, spreadsheet, and analytical software is required.
  • Product lifecycle management software (Arena PLM, Agile PLM, SAP PLM, etc.)
  • Microsoft Office (Word, Excel, PowerPoint, Outlook, Visio, etc.)
  • Graphing and statistical analysis programs (GraphPad Prism, etc.)
  • Quantitative structure activity-relationship models (DEREK, OECD Toolbox, ToxTree, etc.)
  • Metabolite prediction programs (Meteor Nexus, Metaprint2D-React, etc.)
  • Physiologically-Based Pharmacokinetic (PBPK) models