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Job ID :
59247BR
Location :
US - California - Fremont
:
Job Description
DUTIES:
Develop and deliver customer-focused diagnostics for the quality control business.
Partner with renowned investigators at research institutions, industry, and clinical laboratories worldwide.
Perform QC product development using NGS, qPCR or other molecular technologies.
Provide innovative ideas for new molecular technologies products and intellectual property.
Collaborate with molecular biologists, bioinformatics, engineers, product manager, customer support, other internal teams and external scientists.
Coordinate manufacturing of molecular diagnostic products under cGMP and GLP conditions for sale to assay manufacturers.
Responsible for budget development and product costing analysis.
Represent company at scientific meetings.

Number of Employees
Supervised: 5 Employees
1 Scientist II
2 Manufacturing Scientist
2 Staff Scientist

REQUIREMENTS:
Master’s degree in Biotechnology, Molecular Biology, Chemistry or related field of study plus 4 years of biotechnology, molecular biology or related experience. Employer also accepts a PhD degree as an equivalent alternative.

Must have experience or knowledge of:

ISO 13485;
21 CFR Part 820 Quality Systems Regulation;
GLP/GMP;
Design control, product and customer requirement gathering (Voice of Customer), development, validations;
Manufacturing quality control;
Next generation sequencing;
Process optimization;
Drafting manufacturing specifications, standard operating procedures, and manufacturing procedures;
US-IVD and CE-IVD requirements;
Infectious diseases diagnostics;
Oncology diagnostics; and
Business experience in pricing analysis and sales.

TRAVEL:
Travel up to 30% locally and internationally as business needs dictate.




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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