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.

Essential Job Functions

Research and Development Activities

• 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.

Quality/Business Systems Activities

• 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.

Essential Job Requirements

Education

• 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.

Experience & Minimum Qualifications

• 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 problem-solving abilities. Required skills include interpreting data, performing mathematical calculations, drawing informed conclusions, and creating and executing strategies and processes to achieve objectives. Proven capability to lead and coordinate teams to reach targets and assess the success of various programs and projects.
• Track record of assay development and optimization, preferably in tissue- and slide-based settings.
• Track record of establishing and maintaining collaborations with other departments and external organizations.
• Laboratory work experience should include a thorough understanding of principles, theories, and practices of immunohistochemistry assay and cell/molecular biology.
• Experience in DNA/RNA isolation from cells and tissues, sequencing, and designing nucleic acid probes and primers is a plus.
• Hands-on experience with mammalian cell culture and bacterial culture, preferably including cytogenetic specimen preparation, is a plus.
• Preference is given to candidates with antibody and probe product development, immunogen and probe design, design control process, and IVD experience

Other Skills

• Excellent interpersonal skills with the ability to analyze and weigh the opinions of experts in the field of biomarker detection.
• Interact in a professional and proactive manner with internal and external customers.
• Must be able to generate, interpret, and present technical data to meet customer requirements.
• Must orchestrate the technical expertise of all team members in answering customer requirements.
• Must be able to properly assess and coordinate the various requirements of broad areas of activity and make timely decisions.

Physical Requirements & Working Environment

• This position requires the employee to sit and work in a laboratory setting frequently. In addition, the employee is occasionally required to stand, walk, use hands and fingers, and reach with hands and arms.
• Must be able to lift, push and/or pullup to 50 pounds occasionally with assistance.
• Ability to successfully respond to multiple work pressures.
• Ability to travel domestically and internationally occasionally.

"Sakura Finetek USA, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law."

The above description identifies the essential job functions and skills needed by the person or persons assigned to this position. These job functions and skills are not intended to be a complete and exhaustive list of all responsibilities, duties and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. The information contained herein is subject to change at the company's discretion.