Abbott Sr. Scientist, Biocompatibility in St. Paul, Minnesota
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Sr. Biocompatibility Specialist who will make an important contribution to patient safety by supporting projects/programs in terms of biocompatibility of medical devices, materials, and processes. The person will represent the Biocompatibility Group as part of R&D Science and Technology Group as a Subject Matter Expert (SME) in biocompatibility. This role will work closely with program/project cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements such as ISO 10993. The role requires knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidance that affect assigned devices (Class I to Class III). Candidate must have strong ability to interpret biocompatibility regulatory requirements and guidance and support biocompatibility strategy team to correctly apply regulatory requirements as appropriate to product development and change activities for assigned devices. Candidate must have strong ability to critically review detailed scientific information and assess any gaps based on adequately supported data. Candidate must be able to assess project risks and recommend contingency plans and strategies to mitigate risks.
Develop technically sound protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers
Understand biocompatibility strategies that are formed in consideration of gaps in materials, design and process to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety
Evaluate and execute biocompatibility studies in support of programs dealing with Class I to Class III medical devices
Make positive contributions to, recommend approaches to, and support updating/ developing procedures for internal and external guidance document as they relate to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA)
Responsible for assisting biocompatibility strategy team members to identify critical process factors and their effects on biological safety
Support biological hazards risk analysis activities
Interface with key business partners and represent biocompatibility team on project/program teams
Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations
Collaborate with biocompatibility strategy team members to develop strategies and draft answers for regulatory submission responses to biocompatibility related questions
Provide leadership and technical guidance to Scientist/Specialist I and II of the Biocompatibility team
Experiences, education, and knowledge requirements:
BS in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; advanced degree (MS or PhD) in these fields preferred
5-7 years’ industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process validation
Fundamental understanding or direct experience of the ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology
Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverable
Must be team oriented, with the ability to work well with diverse cross-functional teams and to interact at the highest professional manner with all organizational levels
Must possess strong analytical and process skills, and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.
Demonstrated ability to draw conclusions, present and make recommendations based on technical inputs from multiple and varied functions
Excellent communication skills, both verbal and written, and interpersonal skills to effectively interact with and contribute constructively to a global team environment, outside departments and externally
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com