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Thermo Fisher Scientific Molecular Controls Scientist III in Fremont, California

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

Fremont, CA / Clinical Diagnostics Division

How will you make an impact?

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

What will you do?

  • Technical lead for the molecular controls (QC products) manufacturing group

  • Collaborate with R&D and support transfer of complex processes to manufacturing

  • Manufacture complex products following cGMP and completes all necessary documentation in accordance with quality system

  • Lead product and process improvement projects to increase efficiencies

  • Conduct final lot release reviews

  • Performs root cause investigation for non-conformance and CAPA

  • Authors planned deviations

  • Support interdepartmental communication relating to several groups such as: Planning, value stream leaders, Inventory Control, Manufacturing, Customer Service and Shipping

  • Performs other related duties as required and/or assigned

How will you get here?

Education / Experience

  • Bachelor's degree in Molecular Biology, Biochemistry or related field AND 5 years industry experience in IVD medical device field; OR master's degree in Molecular Biology, Biochemistry, or related field AND 3 years industry experience in IVD medical device field

Knowledge, Skills, Abilities

  • Hands-on experience with qPCR, ddPCR, NGS and cell culture

  • Direct working experience with bulk manufacturing process

  • Familiarity with Design Control process

  • Familiarity with Quality System Regulations and ISO 13485 regulations

  • Strong laboratory skills including pipetting, safety, and hazardous chemical handling

  • Must be organized and detail oriented to be able to prioritize own and other's work and meet business productivity metrics

  • Self-motivated, independent, and a proactive driving force of execution

  • Proficient in use of ERP system

  • Embrace PPI and continuous improvement

  • Must be able to lift 25 lbs. routinely

Preferred Qualifications

  • Previous molecular diagnostics experience is a plus

  • Previous experience operating and programming automated equipment such as Tecan and Hamilton is a plus

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 .

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.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.