Sr. Scientist/Principal Scientist
Summary and Scope of Position
Biocompatibility Specialist who will make an important contribution to patient safety by supporting projects/programs in regard to performance of biocompatibility and extractables / leachables (E&L) of medical devices, materials, and processes. The person will represent the CMC-Device group as a subject matter expert (SME) in biocompatibility and E & L.
- Senior-level individual contributor responsible for leading biocompatibility and physicochemical testing of Cerus medical devices, materials, and processes
- Develop technically sound protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers
- Manage external test laboratories involved in the conduct of testing
- Responsible for ensuring compliance with global regulatory requirements and standards related to biological safety such as ISO 10993 and EP/USP.
- Responsible for defining testing strategy based on consideration of gaps in materials, design and process to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety
- Support biological hazards risk analysis activities
- Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable, chemical characterization and biological evaluations
- Serve as a technical expert on project teams, including contribution of ideas, development and execution of plans and timely reporting of results.
- Author SOPs related to biological evaluations of Cerus products
- Author regulatory submissions and responses related to biological evaluations of Cerus products.
- Maintain leading edge knowledge in field of expertise.
- Ph.D., with a minimum of 5 years relevant experience or Master’s degree with a minimum of 10 years of experience. Preferred degrees include: Toxicology, Biochemistry, Biomedical Engineering, Bioengineering, Biology (Biological Sciences)
- Experience in the field of Medical Device, Pharmaceutical, or Biotechnology required, 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 for materials and container-closure systems, 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
- Candidate must have strong ability to interpret biocompatibility regulatory requirements and guidance and support biocompatibility strategy to correctly apply regulatory requirements as appropriate to product development and change activities for assigned devices.
- Candidate must have intimate knowledge of toxicity due to related impurities generated from E & L studies and how to classify and justify for safe use of Class III medical devices
- Candidate must have strong ability to critically review detailed scientific information and assess any gaps based on adequately supported data.
- 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
- Ability to effectively and constructively communicate, coordinate, cooperate and interact with all levels internally (including executive management) and externally.
- Strong leadership and influencing skills in a cross-functional organizational setting.
- Excellent in getting results without direct authority
- Strong analytical mind and attitude to handle multiple projects within Cerus
- Position requires both strategic agility and strong attention to detail and execution.
- Excellent communication, organizational and presentation skills with ability to present the results in project team meetings.
- Requires some U.S. and international travel.