Senior Design Transfer Scientist

Senior Design Transfer Scientist will be responsible for facilitating 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, including next‑generation sequencing (NGS) assays. The candidate will work within the R&D team and collaborate cross‑functionally with operations, bio‑development, bioinformatics, quality, regulatory affairs, and clinical affairs.

• Conduct risk assessments (FMEA) to identify gaps in the process and develop strategies to achieve compliance with IVD standards.
• Design and develop manufacturing, QC, and commercial operations processes.
• Plan and execute laboratory research related to manufacturing scale‑up and process capability improvement.
• Assure experimental quality through sound experimental design; utilize DOE, Cpk analysis, Gage R&R and assist in designing experiments for others.
• Plan and conduct stability studies with assistance from junior team members.
• Lead cross‑functional efforts to establish supply chains for raw materials and consumables, and propose improvements.
• Attend core team meetings, represent operations, and serve as liaison between R&D and Operations.
• Lead test method developments and characterizations.
• Conduct studies to generate specifications and set process and test method specifications based on statistical analysis.
• Lead test method validations and process validations.
• Set up product structures (BOMs), write SOPs, and prepare manufacturing and QC documents.
• Write protocols and reports.
• Play a significant role in PMA submission, audit preparation, and qualification of suppliers and manufacturing processes.
• Present status updates, data, and proposals in forums to technical and non‑technical audiences.
• Lead senior and junior team members.

• bachelor’s degree plus 10 years of relevant experience OR a master’s degree with 7 years of experience OR a 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 in a highly regulated industry.
• Knowledge of quality and regulatory standards and requirements (ISO, CLSI, FDA) – must have.
• 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 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.

This range reflects a good‑faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations. The position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:

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

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

Natera™ is a global leader in cell‑free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world‑class…