Sr. Scientist - Advanced Staining

Job Description

Job Description

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

Essential Job Requirements

Education

Experience & Minimum Qualifications

Other Skills

Physical Requirements & Working Environment

"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.