Experis, a ManpowerGroup company, has an exciting contract opportunity with one of our key clients, a global Pharmaceutical /Medical device company that is engaged in the discovery, development and manufacturer of healthcare products.
Job Title: Biocompatibility Specialist / Scientist
Location: Remote
Duration: 12+ months (possible extension)
TOP Skills:
- Looking for someone coming from Medical Device / Pharmaceutical company
- Experience with Biocompatibility testing
- ISO 10993
- Open to remote - Team is based out CA
- Long term contract role
Job Description Summary:
We are seeking an experienced, Senior Biocompatibility Scientist 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 Abbott R&D Science and Technology Group. This role will work closely with internal biocompatibility SME's and directly with program/project cross-functional teams to provide biocompatibility risk assessments, test strategy and 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 standards/guidance and apply regulatory requirements as appropriate to product development and change activities for assigned devices. Candidate must have strong ability to identify required inputs, critically review and evaluate scientific information, and assess the significance of any gaps identified.
Years Experience:
- 5-7 years' industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process validation Skills:
- Skills: 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
- Demonstrated ability to draw conclusions, present and make recommendations based on technical inputs from multiple and varied functions
- Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with all organizational levels
- Excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site and multi-business unit
- Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables
- Must possess strong analytical and process skills, and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.
- Education: 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) preferred although comparable areas of study and industry experience is considered for the position
Duties:
- seeking an experienced, high caliber Staff Biocompatibility Scientist 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 strategy and 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 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 identify and assess business/technical project risks, and recommend/influence contingency plans for risk mitigation.
Essential Responsibilities:
- Develop biocompatibility strategies in consideration of gaps in materials, design and process to achieve optimal solutions that satisfy timeline, cost and technical requirements as they relate to biological safety
- Critically review protocols, reports, toxicological risk assessments, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers
- Evaluate and execute biocompatibility studies in support of programs dealing with Class I to Class III medical devices
- Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations
- Develop and deliver regulatory submission responses to biocompatibility related questions
- Identify and interface with key business partners and represent biocompatibility team on project/program teams
- Influence organization excellence by recommending approaches, procedures, and work aids as they relate to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA)
- Provide leadership and technical guidance to Scientist/Specialist I and II of the Biocompatibility team"
APPLY TODAY!
Thanks & Regards,
Mridul Singh
Talent Acquisition Specialist
Experis CORE+
Phone: [Phone number shown when applying] Ext: 7192
Text: [Phone number shown when applying]
Email:
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100 Manpower Place, Milwaukee WI 53212