Job Openings

Toxicologist / Principal Scientist

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Location
Oakland, CA
Job Type
Direct Hire
Date
Nov 26, 2019
Job ID
2677457

Toxicologist / Principal Scientist – Extractables & Leachables – Medical Device


Summary:


Seeking Subject Matter Expert (SME) for a Senior Scientific role with biocompatibility and toxicology expertise in Extractables & Leachables for global medical device company. The right person may be able to work remotely, apply if you are interested and qualified.


Responsibilities:


• Senior-level individual contributor responsible testing of medical devices, processes and materials


• Develop protocols, reports, and regulatory summaries in collaboration with cross-functional teams, laboratories and suppliers


• Manage external test labs


• Ensure compliance with global regulatory requirements and standards related to biological safety such as ISO 10993


• Responsible for defining testing strategy based for materials, design and process that satisfy cost and technical requirements


• Analyze biocompatibility testing: extractable and leachable, chemical characterization and biological evaluations


• Author SOPs


• Author regulatory submissions and responses to evaluations


Qualifications


• Ph.D in Toxicology, Biochemistry, Biomedical Engineering, Bioengineering, Biology with 5+ years’ experience or MS Degree with 10+ years’ experience in biocompatibility, toxicology, and/or process validation


• Fundamental understanding of ISO 10993 standards


• Experience with biomaterials, toxicological assessments, E & L analysis for materials, container-closure systems, processes for medical device manufacturing, and biocompatibility assessment


• Must have expertise in toxicity due to related impurities generated from E & L studies and how to classify and justify safe use of Class III medical devices


• Strong ability to critically review detailed scientific information and assess areas for improvement


• Ability to work well with diverse cross-functional teams


• Strong leadership and influencing skills in a cross-functional organizational setting


• DABT Certification is HIGHLY preferred 


• Requires some domestic and international travel