Gilbert Meher are currently partnered with an innovative Molecular Diagnostics company who are defining a new path in the development of Blood Diagnostics.
Recent commercial success has driven growth, and as a result they are expanding their technical teams. They are seeking a Senior/Principal Scientist to lead Biocompatibility testing, acting as the Subject Matter Expert throughout biocompatibility and extractables and leachables, thus driving patient safety.
The successful candidate will report directly into the Vice President of Manufacturing, and will be responsible for:
- Supporting commercial and clinical manufacturing team as the leading responsible for all biocompatibility and physiochemical testing throughout both an existing and developing portfolio of medical devices, materials and processes.
- Ensuring compliance with global regulatory requirements such as ISO10993 and EP/USP.
- Defining testing strategy from reviewing gaps in materials, design and process, ultimately driving the implementation of optimal safety solutions.
- Identify Identifying and managing external testing laboratories as required.
- Authoring SOPs related to biological evaluations.
- Supporting Product Development in the writing of regulatory submissions and responses in relation to biological evaluations.
- Acting as the general SME throughout biocompatibility testing – i.e extractables and leachables, chemical characterisation and biological evaluations.
- PhD educated (preferred degrees include Toxicology, Biochemistry, Biomedical Engineering, Bioengineering, Biology) with >5 years’ relevant experience or MSc educated with >10 years’ experience.
- Experience working in a commercial Medical Device, Pharmaceutical, Biotechnology or Diagnostics environment, with specific biocompatibility, toxicology or special process validation exposure.
- Experience working in line with ISO10993 standards.
- Proven knowledge of biomaterials, toxicological assessment, extractable and leachable analysis for materials and container-closure systems, medical device manufacturing and biocompatibility assessment.
- Ability to interpret biocompatibility regulatory requirements, supporting the development of regulatory strategy as appropriate.
- Proven depth of understanding of toxicology, with the ability to classify and justify safe use of Class III Medical Devices.
The position is to be based in San Francisco, California and will support relocation. If you are interested please apply directly.
Whilst we may not be able to respond personally to each applicant, we appreciate the time you have taken to consider and apply for a new role with us. If you have not heard from us within 4 weeks, then on this occasion your application has not been successful.