Sr. Technical Support Scientist

Research & Development | Irvine, CA

Job Description:

We are seeking a Senior Technical Support Scientist. This individual will Serve as a back-up for TS Scientists to enable technical support for to internal departments, field employees and external customers. Lead/Manage the processing and resolution of technical issues, functional complaints, and corrective action preventive action (CAPA) as needed.  Lead/Manage projects related to application development, technical information collection, customer collaborations and support, and scientific analyses as needed.

Responsibilities:

  • Support their resolution of direct and indirect technical inquiries, internal and external.
  • Serve as a resource for R&D and commercial groups by providing subject matter expertise.
  • Provide product evaluation/feedback based on information gathered through inquiry responses and resolution of functional complaints, and observed trends.
  • Assist in process improvement projects to improve effectiveness of our internal processes.
  • Provide support on projects directly affecting our customers and their adaptation of our products.
  • Analyze product evaluations for performance and technical trends to enhance our technical response to issues and to realize opportunities.
  • Manage and monitor customer inquiries associated with complaints.
  • Manage and coordinate cross functional activities for corrective/preventive action program.
  • Ensure timely closure of customer complaints and that established turnaround times are met.
  • Ensure compliance of processes and procedures to applicable standards related to complaints and formulation disclosures.   
  • Provide technical support, as needed, for the preparation of regulatory submissions for FDA/EU/CMDR or other regulatory agencies.
  • Assisting with changes to product design, specification or production processes and reviewing risk analysis files as required.
  • Developing materials (eg. FAQs) to reduce the number of recurring inquiries on products.
  • Generate reports at a regular cadence to capture the work done on projects.

Experience/Education:

  • PhD. in Cellular Biology or equivalent. Post-doc and/or industry experience strongly preferred.
  • 2 or more years of experience in areas such as Bioproduction, Cell Therapy, Gene Therapy, Cell lines and culture, Cell Growth Medium design and preparation, technical and customer support.
  • Experience in cell and tissues culture. Experience can be from education or industry.
  • Expertise in Areas related to Bioproduction, Cell Therapy, Gene Therapy, Cell Culture.
  • Ability to obtain cooperation from other groups and lead cross functional teams.
  • Strong troubleshooting and root cause analysis skills required.
  • Proficient in Microsoft Word, Excel, PowerPoint, Outlook.
  • Preferred knowledge of GMPs, USP, and ISO 9001/EN13485.
  • Preferred knowledge of ERP system.
  • Excellent command in use of computer and technology.
  • Excellent Excel and Power Point software skills.
  • Writing/Revising Standard Operating Procedures.

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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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