Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

Thermo Fisher’s Clinical Next-Generation Sequencing Group is seeking a hardworking, highly motivated scientist to be a part of the R&D team supporting the development and validation of new NGS based oncology diagnostic applications. The ideal candidate will have a strong understanding of GLP and regulatory requirements for working in a R&D laboratory, proficiency with Microsoft Office applications (Word, Excel), be detail oriented, quality focused and self-motivated, work collaboratively with other members of the team.

What will you do:

Coordinate equipment lifecycle management (IDs, IQOQPQ, PM, calibration, etc.) of equipment in CSD Labs.Schedule and coordinate equipment calibrations and validations with contracted companies.Work closely with site QA to meet and maintain ISO 13485 and 21 CFR compliance and GLP requirements.Assist in updating existing SOPs following QA guidelinesAssist with inventory management (physical reagent allocations, receiving, shipping, cycle count)Be a backup contact for reagent allocations, work closely with operators to support ongoing studies.Be on Call in case of CTU’s malfunctioning, including after hours and weekends.Assist with receiving and shipping of materials following the site SOP and CSD practices.Maintain document files, receiving log and binder.Monitor Lab maintenance following 5S system guidelines, participate in Gemba walks, maintain lab audit readiness.Ensure that safe laboratory procedures and protocols are followed.Assist project leaders and staff scientists in coordinating daily activities.

 Keys to Success:

EducationBachelor’s degree or higher in Chemistry, Biology, Biotech or related fieldsExperience1-2 years experience working in a chemistry, biology, or equivalent lab with emphasis on inventory management and lab maintenanceExperience in a lab setting in life sciences and an understanding of molecular biology and associated techniques preferredHighly skilled at using Microsoft Office (Word/Excel)Knowledge, Skills, AbilitiesStrong practical knowledge and adherence to Good Laboratory Practices and safety protocolsUnderstanding of RUO/IUO/IVD regulatory status and requirementsUnderstanding of BSL-2 lab safety rules, being able to handle hazardous materials and samples of human plasmaExceptional organizational skillsAbility to prioritize assignments and to manage multiple projects in a time-sensitive mannerPossess good written, verbal and interpersonal communication skillsMust be able to work in walk-in freezers or refrigerators periodicallyMust be able to assist with material relocation in case of CTU emergency including after hours and weekends