Senior Scientist - Advanced Staining Reagent Development
General Position Summary
The Senior Scientist has overall responsibility for reagent and product development following design control guidelines to meet the Food and Drug Administration (FDA) regulatory requirements. The incumbent is responsible for development and improvement of reagents for automated and manual immunohistochemistry (IHC) and in situ hybridization (ISH) staining, as well as in other areas as assigned.
Essential Job Functions
Research and Development Activities
- Develops quality reagents and IHC or ISH staining protocols to meet the demands of Sakura's global IHC and ISH market.
- Meets Operations budget.
- Continually monitors productivity and quality and makes improvements.
- Facilitates technology and reagent development process transfers.
- Supports program directives from senior management.
- Develops IHC/ISH reagent lines for existing market.
- Defines and specifies new IHC/ISH reagents, enhancing the reagent portfolio.
- Develops new antibodies and probes to expand the reagent lines, documenting appropriate specificity/sensitivity, precision, robustness, and stability as required.
- Develops and implements growth plans for the IHC/ISH reagent lines.
- Works with all functions within the Sakura group to launch new products.
- Ensures compliance with all applicable environmental, health, and safety regulations.
- Assists in the development, planning, and implementation of product and process development for new products and technologies from the laboratory through manufacturing scale-up.
- Provides technical expertise for all activities within the Reagent Product/Process Development area.
- Participates as needed, on project teams, task forces, business or technical meetings.
- Keeps senior management informed by creating meaningful report summaries of new reagent development activities on a regular basis.
- Provides technical advice to internal and external customers.
- Supports products from early development, finalization, manufacturing and launch.
- Writes and files patent applications as warranted.
- Capable of working with external collaborators on complex scientific projects.
- Presents scientific research findings or new technology in scientific meetings and workshops.
- Performs other duties and projects as assigned.
Quality/Business Systems Activities
- Ensures that Sakura's Quality System is deployed and actively seeks opportunities to continuously improve.
- Adheres to Good Laboratory Practice (GLP), supports any activity that is needed for FDA compliance and/or ISO certification.
- Follows up on R&D action items addressed by different teams and assists in overseeing resolution of quality issues.
- Reviews business opportunities and quality improvements.
- Implements preventive action based on improvement opportunities or trends identified during Leadership Review meetings.
- Initiates action items and assigns responsibilities.
- Identifies Quality Program issues while interacting closely with the Leadership Representative/Quality Program Coordinator.
Essential Job Requirements
- Ph.D. or Master’s Degree in a relevant scientific discipline.
- Theoretical knowledge of immunology, physiology, histology, pathology, and molecular biology, such as 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.
- 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 chemistry and cell/molecular biology.
- Must be proficient in molecular methodologies such as DNA/RNA isolation from cells and tissues, sequencing, and the design of nucleic acid probes and primers.
- Hands on experience with light and fluorescence microscopy, preferably to include expertise with whole slide scanning.
- Hands on experience with mammalian cell culture and bacterial culture, preferably to include cytogenetic specimen preparation.
- 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.
- Track record of assay development and optimization, preferably in tissue- and slide-based settings.
- Must be able to independently troubleshoot assay performance issues.
- Requires clear and concise verbal and written communication skills; good technical writing skills; ability to convey complex technical information in an easily understood manner, both verbally and in writing; good computer skills (word-processing, spreadsheets, Power-Point, etc.).
- Preference given to candidates with antibody and probe product development/immunogen and probe design/design control process/IVD experience.
- Good analytical, organizational, and problem-solving skills.
- Excellent interpersonal skills with ability to analyze and weigh the opinion of experts in the field of biomarker detection.
- Must have excellent written and verbal communication skills.
- 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 simultaneously coordinate product and process development.
- 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 frequently sit. In addition, the employee is occasionally required to stand, walk, use hands and fingers, and reach with hands and arms.
- Must be able to occasionally lift and/or move up to 50 pounds.
- Ability to successfully respond to multiple work pressures.
- Requires reading, math, analyzing and drawing conclusions from data, developing and implementing methodologies/plans/processes for accomplishing a goal, coordinating and leading others to accomplish goals, and evaluating the progress of programs and projects.
- Ability to travel domestically and internationally.
“Sakura Finetek USA, Inc. is an Equal Opportunity employer. All qualified applicants and employees 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.