Design Transfer Scientist

The
Design Transfer Scientist will be responsible for supporting the transfer of products from Development to Operations for an early cancer detection assay. The Scientist will assist in planning, execution, implementation, and documentation of all design transfer activities for an IVD/PMA assay under design control, for next generation sequencing (NGS) assays. The Scientist is expected to divide time between working in the lab and at the desk.

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

• Assist in test method development and characterization
• Plan and execute stability studies
• 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, including product requirements and material specification development
• Perform and document change control activities
• 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

• 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 required
• 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 is highly desired
• Adept with Excel and basic statistical analysis
• Hands‑on experience with statistical tools such as Minitab or JMP
• Experience with scale up and automation projects is a plus
• Experience with molecular biology techniques such as PCR, qPCR and multiplex PCR is a must
• Hands‑on experience with NGS and DNA/RNA molecular biology is a must
• Prior Manufacturing and QC experience is a plus
• IVD product development experience is a plus
• Very strong analytical and problem‑solving skills
• Strong interpersonal and communication skills
• Effective time management and organizational skills; able to balance multiple priorities
• Excellent communication and analytical skills
• Proven ability to execute and deliver on commitments

Austin, TX

$103,700 - $129,600 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.

Competitive Benefits – Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status.