Senior Design Transfer Scientist

Senior Design Transfer Scientist

Position Location:

Austin, TX or San Carlos, CA.

Position Summary

The Senior Design Transfer Scientist will facilitate the transition of products from Development to Operations. The Sr. Scientist will plan, execute, implement, and document all design transfer activities for an IVD/PMA assay under design control, for next generation sequencing (NGS) assays. The successful candidate will work within the R&D and collaborate cross‑functionally with members of operations, bio‑development, bioinformatics, quality, regulatory affairs, and clinical affairs.

The Sr. Scientist is expected to divide time between working in the lab and at the desk and providing training and guidance to junior team members in their creation of design transfer documentation and execution of NGS experiments to support in‑vitro diagnostic (IVD) design transfer. The candidate will maintain a broad knowledge of state‑of‑the‑art principles and theories. This role will also support regulatory IVD and PMA submissions from a design transfer perspective.

The ideal candidate will be an enthusiastic, flexible team member who learns quickly, enjoys multi‑tasking and has an interest in our company and our products.

• 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

• 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
• 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
• Very strong analytical and problem‑solving skills
• Strong interpersonal and communication skills

Compensation Range: $122,100–$152,700 USD.

• Annual performance incentive bonus
• Long‑term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Additional wellness and work‑life benefits

Natera is a global leader in cell‑free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ…