Senior Scientist, R&D Sterility Assurance

Cincinnatti, OH 45242

Posted: 06/26/2019 Industry: Biotech/R&D/Science Job Number: 49160

We are currently recruiting for a Senior Scientist, R&D Sterility Assurance, located in Ohio area.

The Senior Scientist will semi-autonomously develop strategies, protocol and project plans for the sterilization of medical devices, leads the execution of protocols and generates completion reports. Working under minimal supervision the Senior Scientist will conduct research and contribute to the origination and direction of experiments and new methodologies, prioritize tasks according to broad project goals and support technical consultants as needed.


The Senior Scientist will perform the following:
  • Apply scientific principles to new products/technology concepts using creating thinking and innovative techniques
  • Design, develop and validate new innovative test methods for characterizing medical devices and biomaterials
  • Effectively prioritize and manage multiple activities simultaneously
  • Develop test protocols, carry out experiments (including design of equipment/fixtures as needed), analyze test results, and prepare technical completion reports
  • Work with project teams to provide sterilization strategies aimed at supporting product development and regulatory submissions
  • Collaborate with associates of diverse technical and non-technical backgrounds to achieve desired project outcomes
  • Identify and mitigate risks associated with new product development activities in area of responsibility
  • Develop departmental and/or franchise-level procedures in support of company policies
  • Ensure deliverables comply with company and external standards
  • Maintains strong working knowledge of terminal sterilization technologies including radiation, ethylene oxide and moist heat
  • Maintains working knowledge of relevant standards and compendial methods for sterilization and sterility assurance (e.g. AAMI, ISO, ASTM, USP/EP/JP, etc.)


  • Experience in conducting audits of sterilization service providers and ancillary services impacting sterilization
  • A minimum of five (5) years direct experience with medical device and/or diagnostic sterilization processes is required with experience at the Scientist/Engineer level or equivalent external experience
  • B.A./B.S. in life science, engineering, or related scientific/technical discipline required (e.g. biology, microbiology, physics, etc.)
  • MS degree preferred
  • Knowledge and experience in national/international standards in quality management, sterilization methods, microbiology and sterility assurance
  • Demonstrate results in Quality Control, Compliance, and Regulatory
  • Experienced in working with (or leading) multi-functional project teams for the design and validation of sterilization processes for medical products
  • Able to apply strategic thinking & big picture orientation
  • Project management desired
  • Knowledge of statistical techniques for data management, presentation and analysis
  • Customer focus (internal & external) and strong business acumen
  • Strong written & verbal communication skills
  • Results-driven and a sense of urgency
  • Understanding of information technology in order to allow utilization of new technologies to meet business objectives
  • Quality and compliance focus
  • Personal computer software – Windows: word processing, project planning, presentation, e-mail, flow charts & spreadsheet software

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