Position Overview

The Senior Scientist is a critical position responsible for analytical development activities associated with client processes and cell therapy production.  This position provides leadership within a high performing team that will provide analytical development assessments for potential clients, is responsible for providing strong scientific leadership and hands-on support for all aspects of technology transfer, analytical development, lab scale process monitoring, and analytical troubleshooting, and supporting regulatory submissions as needed.  This position has a strong cross-functional partnership with the Cell Therapy Business leaders, Process Engineering, Technology Transfer/New Product Introduction to ensure successful development and transfer, into the site, of all client cell therapy analytical method.

Job Description

An exciting opportunity awaits you as part of our Talent Transfer program to Toyama, Japan! This role will be based on site in Toyama, Japan. The Talent Transfer program offers several benefits such as building new relationships, enhancing our culture of collaboration and gives you a unique opportunity for professional growth and development.   In Toyama we are building a new KojoX facility, scheduled to be completed by March 2027. This facility will provide comprehensive process development and manufacturing services for biopharmaceuticals, ensuring we meet our customers’ evolving needs across Europe, the US, and Japan. 

This role exhibits advanced wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures. In this role, you will lead the development and execution of assays, focusing on development programs. This role involves designing, optimizing, and validating assays often cell-based or ELISA to assess product potency, purity, and other critical quality attributes. This role plays a key role in data analysis, troubleshooting, and mentoring the FUJIFILM Toyama Chemical team.

Principal Accountabilities:

• Provide guidance on techniques for bioassays related to various types of monoclonal antibodies.
• Support the test procedures on the bioassays, especially ELISA.
• Provide the procedures for designing ELISA test methods, methods for performing analytical method validation, and how to decide evaluation criteria.
• Provide the troubleshooting and frequency trouble examples for the methods of ELISA assay performance, data interpretation and instrument operation
• Provide scientific expertise, training, and mentorship to team members.
• Review and verify data generated by others to determine standards with product specifications.
• Propose and possibly implement changes to improve methodology and laboratory techniques.
• Collaborate cross functionally with other departments to ensure integration of ELISA methodologies into overall product development processes.

Education and Experience Requirements:

• This role typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years’ experience; or equivalent experience. Some barriers to entry exist at this level, requiring department review.
• Extensive experience in developing and validating cell-based and/or biochemical assays
• Experience in an analytical development role with significant expertise in ELISA assay development and validation

Knowledge and Skills: 

• Advanced knowledge in analytical methods and respective instrumentation.
• Advanced scientific background with a deep understanding of cell biology, biochemistry, molecular biology and/or immunology.
• Advanced knowledge of product testing and laboratory skills.
• Excellent communication skills with the ability to present scientific findings and collaborate with teams
• Working scientific knowledge (especially bioassays for mAb).
• Working knowledge of ELISA platforms and data analysis software.
• Advanced knowledge in analyzing and interpreting complex datasets.
• Advanced knowledge in analytical method development and qualification (bioassays).
• Working knowledge of investigating process-related issues related to validation execution.
• Advanced knowledge of cGMP experience and method validation preferred.
• Advanced knowledge of other analytical techniques such as HPLC, MS, and Western Blotting.

As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe, Japan, and the United States.