Irvine Scientific, a member of Fujifilm Holdings Corporation, 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 cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large- scale production of biotherapeutics and vaccines. 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 45 years, Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. Additional information can be found at www.irvinesci.com.
We are hiring for a Formulation & Feasibility Scientist. The Formulation & Feasibility Scientist works directly with customers and Fujifilm Irvine Scientific employees to review formulations for manufacturability at concept stage, during product development and after product launch. This role will also provide technical information and support to customers and employees. The Formulation & Feasibility Scientist will also review liquid & powder cell culture media formulas for manufacturability, and ensure accuracy of formulas to meet customers’ requests. This person will also perform raw material identification and vendor selection, troubleshooting, and technology transfer. The Formulation & Feasibility Scientist will also assist in customer’s media formula development requests.
- Review new formulas for manufacturability using existing Fujifilm Irvine Scientific GMP validated processes
- Disposition formulas for immediate JEEVES entry and use or for further discussion or negotiation and development with customers
- Ensure the accuracy of formulas to meet customer expectations
- Prepare formula approval documents for review and approval by customers
- Forward approved formulas to Technical Support Specialists for entry
- Provide answers and/or direction to Technical Support or Purchasing regarding Raw Material specification questions pertaining to new formulas
- Provide feed-back to customers on the manufacturability of their proposed formulations and assist with troubleshooting customer problems related to formulation and use of Media
- Compare formula as entered in JEEVES with submitted formula to insure accuracy, provide appropriate feed-back for improvement of entry process as appropriate
- Provide technical support to Medical Device and Media customers as a member of a technical support team
- Respond to technical inquires and concerns
- Provide internal training and consultation on topics related to formulas
- Work both independently and as part of a team
- B.S. in Chemical Engineering, Biology, or Chemistry
- 3-5 years of experience in an R&D or Manufacturing support role preferably in the pharmaceutical, medical device, or biological industry with three of those years as technical support in a pharmaceutical, medical device, nutraceuticals or powder & liquid cell culture media (preferred)
- Knowledge of GMP and ISO 13485:2011
- Familiarity with FDA QSR’s
- Knowledge of project management concepts
- Experience with design control and writing SOPs
- Formula development
- Basic familiarization with MRP/ERP manufacturing systems
- Excellent written and oral communication skills to resolve complex issues into actionable concepts easy for customers to understand
- Strong organizational and interpersonal skills, detail orientation, the ability to multi-task, meet deadlines and prioritize work
- Good Math skills, computer skills and a good understanding of general Chemistry and Biochemistry
- Proficiency using Microsoft PowerPoint, Excel, Word
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.
Material Requirements Planning
Good Manufacturing Practices