Natera · 1 day ago
Senior Design Transfer Scientist
Austin, TX
Full-time
Onsite
Mid, Senior Level
4+ years expNatera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The Senior Design Transfer Scientist will facilitate the transition of products from Development to Operations, planning and executing design transfer activities for IVD/PMA assays, while collaborating cross-functionally with various teams.
BiotechnologyGeneticsHealth DiagnosticsMedicalWomen's
Responsibilities
Conduct risk assessments (FMEA) to identify gaps in the process and come up with a strategy to make it compliant with IVD standards
Design and develop manufacturing, QC and commercial operations processes
Plan and execute laboratory research in relation to manufacturing scale up and improving process capability
Assure experimental quality through sound experimental design; utilizes DOE, Cpk analysis, Gage R&R and assists in the design of experiments for others
Plan and conduct stability studies with assistance from junior team members
Lead cross functional efforts in establishing supply chain for raw materials and consumables and propose improvements
Attend core team meetings, serve as a voice of operations and liaison between R&D and Operations
Lead test method developments and characterizations
Conduct studies to generate specifications
Set process and test method specifications based on statistical analysis
Lead test method validations and process validations
Set up product structures (BOMs), write SOPs, manufacturing and QC documents etc
Write various protocols and reports
Significant role in PMA submission, audit prep and qualification of suppliers and manufacturing processes
Present status update, data and proposals in various forums to technical and non-technical audiences
Lead junior members of the team
Qualification
Required
Bachelor's degree plus 10 years of relevant experience OR a Master's degree with 7 years of experience OR PhD with 4 years of experience required
Strong scientific background in molecular and cell biology, Biotechnology, or Biochemistry
Extensive 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) is a must
Ability to follow and establish SOPs and in-depth knowledge of GLP/GMP guidelines
Very strong analytical and problem-solving skills
Strong interpersonal and communication skills
Preferred
Experience authoring study plans, protocols and study reports is highly desired
Adept with Excel and basic statistical analysis
Hands-on experience with statistical tools such as Minitab or JMP
Supervise junior scientists and team members in their experimental execution and technical documentation
Experience with nucleic acid technologies relating to NGS, PCR, qPCR and multiplex PCR
Hands-on experience with NGS and DNA/RNA molecular biology is preferred
IVD product development experience is a plus
Benefits
Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
Free testing in addition to fertility care benefits
Pregnancy and baby bonding leave
401k benefits
Commuter benefits
Generous employee referral program
Company
Natera
Natera specializes in cell-free DNA testing to provide a more targeted interventions to oncology, women's health, and organ health.
5001-10000 employees
H1B Sponsorship
Natera has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (90)
2024 (72)
2023 (37)
2022 (71)
2021 (64)
2020 (40)
Funding
Current Stage
Public CompanyTotal Funding
$1.16BKey Investors
Sofinnova InvestmentsLightspeed Venture PartnersSequoia Capital
2023-09-07Post Ipo Equity· $250M
2022-11-15Post Ipo Equity· $400.05M
2022-03-16Post Ipo Equity· $5M
Leadership Team
Steve Chapman
CEO
Jonathan Sheena
Co-Founder, Board Member
Recent News
2026-01-06
Company data provided by crunchbase