Scientist III, Molecular Biology
US - Texas - Austin Update time: October 14,2020
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.
The Scientist III is part of the commercial organization supporting Clinical Next-Generation Sequencing Division portfolio which supplies “sample to answer” Instrument, software and reagent solutions, has a leading position in research markets and is the market leader in targeted sequencing and clinical next-Generation Sequencing. This position will reside in Austin, TX.
How will you make an impact?
The successful candidate will develop and validate IVD NGS assays using Ion Torrent technology with the objective of meeting FDA regulatory requirements and launching quality products in the field of Oncology. You will apply your management and laboratory skills and experience working in the regulatory environment for IVD product development (i.e. verification & validation testing). The ability to communicate with stakeholders, meticulously document detailed work, and communicate results to diverse audiences will be required for success in this role.
What will you do?
Education
The Scientist III is part of the commercial organization supporting Clinical Next-Generation Sequencing Division portfolio which supplies “sample to answer” Instrument, software and reagent solutions, has a leading position in research markets and is the market leader in targeted sequencing and clinical next-Generation Sequencing. This position will reside in Austin, TX.
How will you make an impact?
The successful candidate will develop and validate IVD NGS assays using Ion Torrent technology with the objective of meeting FDA regulatory requirements and launching quality products in the field of Oncology. You will apply your management and laboratory skills and experience working in the regulatory environment for IVD product development (i.e. verification & validation testing). The ability to communicate with stakeholders, meticulously document detailed work, and communicate results to diverse audiences will be required for success in this role.
What will you do?
- Development of IVD oncology products for our sequencing systems based on Ion Torrent sequencing technology
- Involved in the entire product development process from concept to product release
- Independently design and perform laboratory experiments and analyze the results by applying her/his knowledge in molecular biology
- Maintain complete and thorough documentation required to meet Design Control compliance, ISO 13485 regulations, as well as other international standards required for high quality development of research use products (RUO) as well as developing in vitro diagnostics (IVD)
- Basic molecular biology techniques: qPCR and multiplex PCR, DNA and RNA isolation and characterization
- Anticipates needs and problems while creating solutions
Education
- Degree in biochemistry, chemistry, molecular biology, or related degree
- PhD degree with limited experience
- MS + 2-3 year relevant industry experience
- BS + 5 years relevant industry experience
- Self-motivated, capable of multi-tasking and able to ensure focused and timely execution of projects
- Experience with development of IVD products
- Experience with Ion Torrent instruments and sequencing applications
- Hands on experience with NGS technologies or a very strong understanding of Ion Torrent sequencing technology
- Must be skilled in basic molecular biology techniques: qPCR and multiplex PCR, DNA and RNA isolation and characterization
- Ability to summarize technical data and present effectively to a variety of audiences
- Expert in all Microsoft Office applications, particularly MS Excel, MS Word, and MS Powerpoint
- Work as part of a team and enthusiastically help others on the team achieve their goals on time
- Strong work ethic to generate high quality data under tight deadlines in a fast-pace environment
- A collaborative and proactive attitude a must
- Demonstrates a sense of urgency, contagious optimism and a “can do” attitude
- Curious, inquisitive, innovative, never satisfied with the status quo
- Greets challenge and change as opportunity
- Experience in an industrial setting is preferred
- Experience with oncology samples from FFPE tissues or liquid biopsy samples preferred
- Experience calling oncology mutations from clinical samples using NGS data preferred
- Practical experience running Ion Torrent Sequencing instrumentation preferred
- Experience working with regulatory partners and contributing to PMA documentation preferred
- Experience developing products for a diagnostic or pharmaceutical company preferred
- Experience working on a core team with project management is advantageous
- Strong laboratory and technical hands on skills required:
- Pipet and perform procedures reproducibly
- Perform a dilution series to create a standard curve
- Perform lab calculations needed to make solutions from powder or from stock solutions and able to make the buffers from recipes
- Operate most basic lab equipment such as computers, centrifuges, UV light box and camera, quantitation instruments, Agilent Bioanalyzer, PCR and qPCR instruments, plate reader
- Routine experience with most common molecular procedures such as nucleic acid isolation, PCR, RT-PCR…
- Basic knowledge of word processing, spreadsheet programs, powerpoint, e-mail and searching the internet.
- Good writing & presentation skills
- Strong documentation and strong organizational skills
- Works well in a team setting
- Works in a laboratory environment.
- Is required to lift up to 40 lbs.
- May be required to stand for long periods of time while performing duties.
- Must be able to work safely with chemicals and hazardous materials.
- Must be able to work flexible shifts.
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