IVD Mol Bio Lab Mgmt and Quality Compliance
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 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 both RUO and 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?
How will you get here?
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 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 both RUO and 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?
- Ensure that lab is maintaining compliance with IVD development standards and ISO13485/ISO9001 requirements
- Manages calibration activities, training records, and receipt of materials for the lab
- Will need to maintain complete and thorough documentation required to meet Design Control, as well as other international standards (e.g., ISO compliance, GLP/GMP requirements, etc.)
- Receive clinical samples for testing and maintain in a validated database
- Ensure all instrumentation is entered and maintained in a validated database to document IQ/OQ/PQ activities and maintain calibration on all instrumentation in the lab
- Complete documentation to maintain design control throughout product development cycle
- Needs to be self-motivated, capable of multi-tasking and able to ensure focused and timely execution of projects
- The candidate must understand basic molecular biology techniques: qPCR and multiplex PCR, DNA and RNA isolation and characterization
- The successful candidate will be able to work as part of a team and enthusiastically help others on the team achieve their goals on time
- May be required to perform other related duties as required and/or assigned
- A strong work ethic to generate high quality data under tight deadlines in a fast-pace environment, collaborative and proactive attitude a must
How will you get here?
Education
- Degree in biochemistry, microbiology, molecular biology, or related degree
- PhD degree with minimal experience
- MS + 2-3 year relevant experience
- BS + 5 years relevant experience
Experience
- A comprehensive background in molecular biology, biochemistry, or a related field
- Experience in IVD development environment or lab
- Experience writing and implementing quality focused procedures in a life sciences laboratory
- Experience in clinical setting or CLIA certified laboratory
- Direct experience and good understanding of design controls and PMA/510(k)submission needs
- Excellent organizational, record keeping and communication skills
- Anticipates needs and problems while creating solutions
- Demonstrates a sense of urgency, contagious optimism and a “can do” attitude
- Is curious, inquisitive, innovative, never satisfied with the status quo
- Greets challenge and change as opportunity
- Collaborates effectively with others
- Experience in Next Generation Sequencing (NGS) is a plus
- submission requirements is a plus
- Experience with CE-IVD certification is a plus
- Track record in direct development of products that led to successful PMA/510(k) submission is a plus
- 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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