The Biomaterials Scientist/Engineer is a member of Materials Science and responsible for assisting in providing knowledge and expertise to ensure that materials performance is aligned with the specific intentions of the user, the regulations that dictate GMP practices and patient safety.This individual will assist in providing materials integrity, accuracy, and consistency across the CBM organizations that are involved in the use and transformation of materials in processes, as a drug product or in contact with the drug product, as raw and ancillary materials and intermediates or in materials selection, specification and source.
This individual will serve on multidisciplinary teams to affect the flow of materials and materials information from client to release for manufacturing.You will contribute to the definition, creation and defense of new materials specifications and participate in the investigation and vetting of their suppliers and manufacturers.You will provide materials expertise to internal organizations that require assistance in materials selection and compatibility.
The biomaterials scientist/engineer will contribute to the development of a hybrid internal and external extractables and leachables (E&Ls) evaluation and testing program.You will be involved in all aspects of product and process development, tech transfer where biomaterials are involves and will be expected to apply your skills and knowledge more broadly across other CBM business units as required.You will review and author technical reports and the open literature to remain cognizant on current trends especially in C> and single use systems.You will author / contribute to risk assessments involving particulates and E&Ls and other aspects of materials science and engineering as required.
- Responsibility focus:cell & gene therapy reagents and systems materials – materials of biological and non-biological origin,
- Work in project teams to usher new materials through for use in GMP manufacturing insuring they are properly specified, characterized and aligned with their intended use.
- Evaluate, codify and amass knowledge of all aspects of materials attributes, origin, use, storage, contact issues, viability, testing, knowledge of process use, biological functioning.
- Establish C> knowledge of process (KoP) / materials relationships and serve as SME to members of materials science and other organizations as needed.
- Provide or develop CBM-relevant expertise in biosurface stability and dynamics, particulate generation, extractables and leachables,
- Develop predictive capabilities to streamline evaluation of complex processes and products
- Work with other material science members to develop predictive materials behavior tools to aid in the evaluation of complex assemblies or configurations where absence or difficulty in acquiring empirical data exists.
- Contribute to the evaluation of material, material supplier & manufacturer, sampling and testing plans of critical biomaterials and attributes.
- Where necessary obtain empirical data or perform tests or arrange for internal or external testing of materials to ensure functionality, performance and compatibility.
- Support transfer of knowledge among CBM organizations.
- Provide direct support to drug product and drug process development systems, support multiple projects at different stages of development.
- Serve as a the Materials Science core team member for client sponsored programs.
- Contribute to the overall smooth flow of materials and materials information throughout the CBM.
Education & Experience
- Advanced degree (MS or Ph.D.) or equivalent experience in biomaterials, biology, materials science or engineering or relevant area of scientific research
- Strong written and oral communication skills
- Experience with cell and gene therapy and or biopharm materials and products
- Experience with materials characterization and analytical instrumentation
- Microsoft Excel expertise and proficient in the MS Office / Windows environment
The following experiences are a plus:
- Experience working in a burgeoning entrepreneurial environment
- Knowledge of the USP, and Eu. Ph., Jp. Ph., …, ISO standards
- Experience with extractables & leachables, biocompatibility, toxicological and particulate assessment (ISO 10993)
- Knowledge of materials modeling and properties computation
- Analysisand interpretation of data, with use of data analysis tools (JMP, Minitab, … )