Sherlock Biosciences, an exciting new diagnostic company based on next-generation CRISPR and Synthetic Biology technology platforms, is seeking an outstanding Senior Scientist to develop and launch molecular diagnostic products. The successful candidate will be responsible for the planning and execution of research and development activities and contributing to strategic direction of new products. In addition, the successful candidate will help drive the innovation of the platform and translate improvements into new products.
This role provides strategic and technical leadership in defining and achieving assay and product development objectives while ensuring compliance with health authority requirements. The Senior Scientist will also contribute to partnering activities with life cycle teams and internal as well as external business partners to drive innovation and product development. This role will drive continuous improvement within product development processes and manage resources to achieve business results within budget. Successful candidates will join an exciting and fast-paced team focused on improving human health worldwide through highly innovative CRISPR and Synthetic Biology-based platforms for molecular diagnostics.
- New Assay and Product Development – Conduct feasibility studies. Develop reagents within design control process and oversee validations. Conduct and oversee research and development of new products, as well as the transfer of products to Operations.
- Oversee critical reagent development, validation, and transfer to Operations.
- Project Management – Manage deliverables in the development and commercialization of reagent applications and new product development.
- Direct analytical studies for Marketing and FDA approval and ensure GMP, ISO and IVDD compliant documentation.
- Interview and hire staff, provide performance feedback and mentorship.
- Responsibilities also include developing workforce planning models and developing skill sets within team to meet future technology requirements.
- Monitor work to ensure quality, and continuously promote First Time Quality.
Skills, Qualifications, and Experience:
- Ph.D. in Bioengineering or Life Sciences with a minimum of 1 year of industry experience, or M.S. in Bioengineering or Life Sciences with minimum of 3 years industry experience
- Direct experience in an IVD company.
- Demonstrated accomplishments in assay development under design controls.
- Management experience a plus.
- Strong background in assay development, including nucleic acid manipulation and detection, immunoassay and immunohistochemistry, or in situ hybridization.
- Demonstrated knowledge of cell and molecular biology, pathology, histology, or biochemistry with technical aptitude to learn different scientific applications quickly.
- Experienced in IVD product development and FDA submissions.
- Excellent leadership and communication skills, creative problem solver in technical areas.
- Familiarity with the various regulatory requirements (GMP, ISO and IVDD).
- Must work well with cross functional teams.