Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you’ll help solve some of the world’s toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

Location/Division Specific Information

Austin, Texas/Clinical Sequencing Division

Education

BS with minimum of 3years relevant experience or MS Degree/ PhD Degree, 1+ years of industry experience in a product development environment. Regulated background experience required.

Required Responsibilities

Will apply technical knowledge to develop kits/reagents/instruments/workflows for sample to sequencing workflows from various sample typesDevelop and or test a hypothesis by performing the necessary set of experiments to test the hypothesisParticipate in innovation of new technologies and application for sample to answer workflows. Activities include chemistry innovation, new instrumentation development and full application workflow developmentAnalyze the data derived and explain the outcome of their experimentsMaintain accurate and detailed lab notebooks and appropriate documentation based on the scientific method enabling other scientists to reproduce their experimentsSupport the preparation of data for manuals, patents or scientific publicationsPrepares regular reports documenting experimentsPresents research data and conclusions in 10-30 minute sessionsAble to exercise good judgment within generally defined procedures, laboratory methods and techniquesNew product commercialization experienceExperience with LDTs, CDx and FDA approval processAlign with FDA Design Control guidance and regulations and the EU In Vitro Diagnostic Medical Device Regulation (IVDR)

Knowledge, Skills, Abilities

Strong laboratory and technical hands on skills requiredStrong molecular biology and clinical product development backgroundExperience with nucleic acid purification automation and different technologies to isolate nucleic acid requiredExperience working in BSL2 lab setting requiredStrong knowledge of word processing, spreadsheet programs, powerpoint, and statistical analysis requiredStrong writing & presentation skills requiredExcellent communication skills for a broad range of audiences.Ability to innovate and generate new products and intellectual property.Strong documentation and strong organizational skills requiredWorks well in a team settingPays attention to detailBe agile with changing environments and execute tasks timelyShows initiative by taking on new tasks, beyond what is generally expectedGenerates ideas to improve current processesSets example by demonstrating excellenceDemonstrates leadership qualitiesHelp coordinate tasks within the teamProduct development experience requiredExperience with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics.Understanding of Quality Systems Regulations and cGMP product development.Experience with leading and working with diverse project teams

Physical Requirements / Work Environment

BSL2 laboratory setting

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!