Sr. Scientist - Advanced Staining

General Position Summary

The Senior Scientist has an overall responsibility for reagent and product development following design control guidelines to meet Food and Drug Administration (FDA) and the in‑vitro medical devices Regulation (IVDR) regulatory requirements. The incumbent is responsible for developing and improving reagents and assays for automated and manual immunohistochemistry (IHC) and in situ hybridization (ISH) staining and in other areas as assigned.

• Develop quality reagents and IHC or ISH staining protocols to meet the demands of Sakura's global IHC and ISH market.
• Develop new antibodies, probes, and IHC/ISH detection reagents to expand the reagent lines, documenting appropriate specificity/sensitivity, precision, robustness, and stability as required.
• Continually monitor productivity and quality and make improvements.
• Facilitate technology and reagent development process transfers.
• Support program directives from senior management.
• Perform microscopic interpretation of stained slides.
• Work with the project manager and team to develop and launch new products.
• Ensure compliance with all applicable environmental, health, and safety regulations.
• Develop, plan, and implement product and process development for new products and technologies from the laboratory through manufacturing scale‑up.
• Provide technical expertise for all Reagent Product/Process Development activities.
• Participate as needed in project teams, task forces, and business or technical meetings.
• Provide technical advice to internal and external customers.
• Support products from early development, finalization, manufacturing, and launch.
• Write and file patent applications as warranted.
• Capable of working with external collaborators on complex scientific projects.
• Present scientific research findings or new technology in scientific meetings and workshops.
• Perform other duties and projects as assigned.

• Ensure that Sakura's Quality System is deployed and actively seek continuous improvement opportunities.
• Adhere to Good Laboratory Practice (GLP) and support any activity that is needed for FDA and IVDR compliance and/or ISO certification.
• Follow up on R&D action items addressed by different teams and assist in resolving quality issues.
• Implement preventive action based on improvement opportunities or trends identified during Leadership Review meetings.
• Initiate action items and assign responsibilities.
• Identify Quality Program issues while interacting closely with the Leadership Representative/Quality Program Coordinator.

• Ph.D. or master's degree or equivalent in a relevant scientific discipline.
• Experience in tissue histology or pathology.
• Theoretical knowledge of antibodies, immunohistochemistry, various antibody conjugation, immunology, histology, pathology, and molecular biology is typically acquired by study in the relevant scientific discipline.

• Minimum of five years of laboratory experience, including independent experimental design, data collection, interpretation, and report writing.
• Must have demonstrated expertise with histology and anatomic pathology methods, including IHC/ISH staining and microscopic interpretation of stained slides.
• Must possess essential knowledge of immunochemistry, histology, and molecular biology methods.
• Must be proficient in immunohistochemistry and in‑situ hybridization methodologies on formalin‑fixed, paraffin‑embedded human tissues such as antibody development/characteristic/production, immunohistochemistry detection system, and antibody conjugations.
• Must be able to troubleshoot assay performance issues independently.
• Practical experience with light and fluorescence microscopy, ideally including proficiency in whole slide scanning. Requires clear and concise verbal and written communication skills, strong technical writing abilities, and the capacity to present complex technical information in an easily understandable manner. Proficient computer skills, including Excel Spreadsheets, and PowerPoint.
• Excellent analytical, organizational, and…