R&D Research Scientist

Overview

FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company's consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.

We are hiring an R&D Research Scientist. The R&D Research Scientist will conduct research under the direction of a supervisor leading to the development of new or improved products in Assisted Reproductive Technologies.

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External US

Responsibilities:

• Plan, design, and conduct experiments related to the development of new products/technologies, or improvement of existing products
• Contribute to the generation of new project/product ideas
• Work closely with the Technical Support team to investigate technical issues with commercialized products, develop plans of action, execute on plans, and achieve a resolution; This may be in the form of corrective action preventive actions (CAPA)
• Perform technical evaluations on products
• Provide scientific support, as needed, for the preparation of regulatory submissions for FDA/EU/CMDR or other regulatory agencies
• Effectively and consistently communicate with management, cross-functional partners and relevant stakeholders on progress towards milestones and forthcoming program needs
• Be involved with experimental strategy development and work on complex and challenging problems in which analysis of situation or data requires a review of identifiable factors
• Perform data analysis, prepare formal reports and presentations
• Actively participate in group/project meetings
• Update job knowledge by participating in educational opportunities and reading technical publications
• Document data and relevant research information

Experience/Education:

• BS in Life Sciences, Biochemistry, Biomedical Engineering or equivalent; MS preferred
• Minimum 8 years of relevant working experience
• OR PhD with minimum of 2 years of relevant working experience

Knowledge:

• Ability to demonstrate potential for technical proficiency, scientific creativity, collaboration with others and independent thought
• Advanced knowledge of biochemistry, or life sciences.
• Advanced knowledge of project management
• Proficient in interpersonal, organizational and time management skills
• Some knowledge of cell culture medium components and cell culture media development a plus
• Some knowledge of Medical Device development preferred
• Familiarity with Regulatory Affairs, Quality Control and Production preferred
• Proficient computer and statistical skills
• General knowledge of GMP and GLP procedures.

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates 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.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.