Skip to main content
Premium Trial:

Request an Annual Quote

Staff Scientist, Process Development & Technology Transfer

Organization

Thermo Fisher Scientific

Job Location

46500 Kato Road
Fremont, CA 94538
United States

Salary

Competitive base salary based upon background, experience & education

Benefits

Comprehensive benefits & bonus package

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

Location/Division Specific Information
Fremont, CA / Clinical Diagnostics Division

How will you make an impact?
You will be the technical partner to the R&D team throughout the life cycle of Cascadion Instrumentation Manufacturing/Operations in cross-functional core teams for product development. You will use your technical knowledge to solve assay design challenges encountered during the course of assay development, clinical validation, or manufacturing validation. Your responsibilities will involve heavy interaction within R&D, Manufacturing Engineering, Manufacturing, and Quality teams.

What will you do?
• Actively participate in the development of new products as a representative of the Technical Transfer team to ensure compatibility with current and future manufacturing processes and capabilities
• Lead, coordinate, or participate in operations-related activities required for the transfer of new products to routine production which will include:
o production scale-up
o process development/optimization
o technology transfer
o process validation
o test method validation
o Design Control Experience
• Partner with R&D team to assess manufacturability throughout the life cycle of new products
• As appropriate, serve as a technical liaison for other departments with regards to new product introduction activities
• Develop and maintain production documentation including but not limited to procedures, worksheets, and bills of materials
• Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies

Requirements

How will you get here?
Education

• Bachelor’s/Master's degree in Molecular Biology, Biochemistry, Chemistry, Chemical Engineering or related discipline with 10+ years of diagnostic industry experience
OR
• Doctoral degree in Molecular Biology, Biochemistry, Chemistry, Chemical Engineering or related discipline with 5+ years of medical device industry experience

Experience
• Experience with regulated product development
• Technical background in immunoassay, biochemical assays
• Experience with development phases including validation and transfer to manufacturing
• Experience with DOE and analysis of large data sets through statistical analysis
• Experience in diagnostics development working with HPLC and GC/MS

Knowledge, Skills, Abilities
• Strong knowledge in Quality System Regulations ISO 13485 and medical device regulations in US and CE markets
• Ability to multi-task and lead projects through R&D to commercial
• Ability to lead and mentor a team, often designated as a substitute for the manager
• Ability to conduct and lead deep dive sessions related to technical issues
• Excellent communication skills

This position has not been approved for relocation assistance.

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Apply today! http://jobs.thermofisher.com

How to Apply

Interested? Great!  Please go to: 

https://jobs.thermofisher.com/global/en/job/15171…?utm_source=Genomeweb&utm_medium=JobPosting&utm_campaign=R&D                                   

About Our Organization

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

For more information, please visit www.thermofisher.com