Senior Scientist II- Process Development

Process Sciences | Santa Ana, CA

Job Description:

FUJIFILM Irvine Scientific had a new opportunity for a Senior Scientist II in Process Developent. In this position, our team member willl provide technical leadership in support of commercialized products, late-stage product development, process development, and new product evaluations to meet company standards and customer expectations.

Responsibilities:

  •  Develop experimental strategies and plans to improve manufacturing processes for commercialized products and products in development.
  • 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).
  • Apply scientific/engineering principles and techniques to develop, characterize, analyze and implement processes to solve technical challenges.
  • Supervise and conduct experimental work related to support and/or improve marketed products.
  • Develop new applications for products and processes to meet customer needs based on feedback from customers.
  • Design and execute scale-up and tech transfer of products for products in late stage product development depending on project needs.
  • Perform technical evaluations on internal products or external products (e.g. potential OEM or licensing opportunities) considered for addition to the portfolio as needed.
  • Provide scientific support, as needed, for the preparation of regulatory submissions for FDA/EU/CMDR or other regulatory agencies.
  • Work with internal legal team to organize and facilitate administrative actions to support the intellectual property portfolio.
  • Support marketing and new products through presentations, publications, collaborative studies, interactions with key customers and as a participant in conferences.
  • Contribute to development of long-range plans for R&D.
  • Learn, maintain and advance expertise in areas relevant to company’s products and strategic goals.
  • Effectively and consistently communicate with management, cross-functional partners and relevant stakeholders on progress towards milestones and forthcoming program needs.
  • Effectively manage employees if managing is required

Experience/Education:

  • Ph.D. with more than 5 years of relevant experience in Life Science, Biochemistry, Cell Biology, or related science.
  • Minimum five years of relevant experience, with emphasis in cell culture.
  • Cell culture experience.
  • Broad scientific knowledge of Chemistry, Biochemistry, Cell Biology, and Microbiology.
  • Experience with conducting and creating new assays as needed.

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Principals only. No recruiters please.

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.

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