Senior Scientist - Bioscience Reagent Development

General Position Summary

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 automated IHC and ISH staining reagent, process and instrumentation improvement.

Essential Job Functions

Essential Job Functions

  • Develops quality reagents and automated IHC or ISH staining protocols to meet demands of Sakura’s global immunohistochemistry 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 reagent lines for existing market.
  • Defines and specifies new immunochemistry reagents, enhancing the reagent portfolio.
  • Develops new antibodies and probes to expand the reagent lines
  • Develops and implements growth plans for the immunohistochemistry 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. 
    Other 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.
  • Interacts 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. 

Education

  • Ph.D. Degree in a relevant scientific discipline or equivalent combination of education and experience.
  • 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 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 biology.
  • Hands on experience with immunofluorescense and fluorescence microscopy.
  • Hands on experience with mammalian tissue culture.
  • Must have a working knowledge of histology and pathology, including preparing histological slides for microscopic examination, immunohistochemical staining, and microscopic interpretation of stained slides.  
  • Must possess essential knowledge of immunochemistry, histology, and molecular biology methods.
  • Must be able to independently troubleshoot assay performance issues.
  • Minimum of five years of laboratory experience including independent experimental design, data collection, interpretation 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 biology.
  • Hands on experience with immunofluorescense and fluorescence microscopy.
  • Hands on experience working with hydrogels, biopolymer chemistry and protein purification.
  • Hands on experience with mammalian tissue culture.
  • Must have a working knowledge of histology and pathology, including preparing histological slides for microscopic examination, immunohistochemical staining, and microscopic interpretation of stained slides.  
  • Must possess essential knowledge of immunochemistry, histology, and molecular biology methods.
  • Must be able to independently troubleshoot assay performance issues.

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, evaluating the progress of programs and projects.
  • Ability to travel domestically and internationally.
Equal Opportunity Employer
Affirmative Action Employer

10/17

SPECIFIC JOB EMPLOYMENT CONTACT INFORMATION:

Sakura Finetek USA, Inc.
Attn: Human Resources Department
1750 West 214th Street
Torrance, CA 90501

Email: jobs@sakuraus.com
Fax: 310-782-7495