Sr. Scientist I – Process Development

R&D | Santa Ana, CA

Job Function:

We are hiring a Sr. Scientist I – Process Development. This is an incredible opportunity for a Scientist to lead and support process development activity within FUJIFILM Irvine Scientific. We are also looking for the person to be an effective communicator and capable of initiating and leading discussions with the R&D group and other technical people.

Job Duties:

  • Develop experimental strategies and plans to improve manufacturing processes for commercialized products and products in development
  • 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
  • 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)
  • Design and execute scale-up and tech transfer for products in late stage 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
  • 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
  • Exercise independent judgment in developing methods, techniques and evaluation of criteria for obtaining results to broadly defined objectives dictated by trends in business and the current product plan

Experience/Education:

  • PhD with more than 5 years or MS with a minimum 8 years of relevant experience in process development in Life Science, Biochemistry, Cell Biology, or related science
  • Minimum five years of relevant experience (scientific and process development) with emphasis in cell culture
  • Capable of working on problems of extreme complexity and challenging nature requiring in-depth evaluation of intangible variables
  • Experience in technology and process improvements, and corrective action preventive actions (CAPA)
  • Experience with conducting and creating new assays as needed
  • Experience in medical device is a plus
  • Experience in writing SOPs
  • Requires substantial independent judgment, creativity and self-motivation
  • A team player
  • Strong verbal and written communication skills with professional presence

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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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