Full-Time
Design Transfer Scientist
Posted on 5/7/2024
Specializes in cell-free DNA testing for healthcare
Mid, Senior
Austin, TX, USA
- Bachelor's degree plus 8 years of relevant experience OR a Master's degree with 5 years of experience OR PhD with 2 years of experience
- Strong scientific background in molecular and cell biology, Biotechnology, or Biochemistry
- Knowledge of design control
- Experience working to policies; procedures and international quality standards or in a highly regulated industry
- Knowledge of quality and regulatory standards and requirements (ISO, CLSI, FDA)
- Ability to follow and establish SOPs and in-depth knowledge of GLP/GMP guidelines
- Experience authoring study plans, protocols and study reports
- Adept with Excel and basic statistical analysis
- Hands-on experience with statistical tools such as Minitab or JMP
- Experience with nucleic acid technologies relating to NGS, PCR, qPCR and multiplex PCR
- Hands-on experience with NGS and DNA/RNA molecular biology
- IVD product development experience is a plus
- Strong analytical and problem-solving skills
- Strong interpersonal and communication skills
- Effective time management and organizational skills
- Excellent communication and analytical skills
- Proven ability to execute and deliver on commitments
- Conduct stability studies
- Assist in test method development and characterization
- Participate in specification generation
- Assist in test method validations and process validations
- Collaborate cross functionally to establish supply chain for raw materials and consumables and propose improvements
- Participate in collaborative efforts with R&D and subject matter experts for successful transfer of new product designs
- Perform and document change control activities
- Set up product structures (BOMs)
- Write standard operating procedures (SOPs), study protocols, reports and other documentation
- Day-to-day “hands on” work in the laboratory including generating, recording, and analyzing experimental data
- Present status update, data and proposals in various forums to technical and non-technical audiences
- Other duties as assigned
At Natera, employees contribute to a global leader in cell-free DNA testing, an essential field for advancements in oncology, women's health, and organ health. The company's strong commitment to validation through over 100 peer-reviewed publications highlights a dedication to data-driven results and continuous improvement, making it a place of rigorous scientific endeavor and innovation. Here, one can actively participate in shaping the future of personalized healthcare decisions, fostering a dynamic and impactful work environment.
Company Stage
IPO
Total Funding
$1.2B
Headquarters
Austin, Texas
Founded
2004
6 month growth
↑ 8%1 year growth
↑ 15%2 year growth
↑ 23%Benefits
Flexible medical plans
Investment options
Time off
Workplace perks