Senior Scientist, R&D Design Transfer & Product Development

POSITION SUMMARY:

The Senior Design Transfer Scientist will lead and support the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations. This role is responsible for planning executing and documenting all design transfer activities while ensuring strict compliance with regulatory and quality standards. The ideal candidate will balance hands-on laboratory work data analysis and documentation. As a cross-functional collaborator you will interface with multiple functional groups to drive project deliverables to completion in a dynamic fast-paced environment.

PRIMARY RESPONSIBILITIES:

• Design Transfer & Validation: Plan and execute process validations (IQ/OQ/PQ) stability studies and study protocols; perform data analysis and author final reports
• Test Method Development: Support test method development characterization and Test Method Validation (TMV) including the generation of manufacturing specifications
• Quality & Risk Management: Lead Risk Management activities (including FMEAs) to identify and mitigate product risks; establish and maintain Design History Files (DHF) and Device Master Records (DMR)
• Sustaining & Change Control: Lead change control activities to evaluate and determine the impact of design changes to on-market products
• CAPA & Troubleshooting: Investigate product or process deviations perform root cause analysis and implement Corrective and Preventive Actions (CAPA)
• Cross-Functional Collaboration: Partner with Supply Chain to establish raw material and consumable pipelines; present status updates data and technical proposals to cross-functional stakeholders

EDUCATION & EXPERIENCE:

• PhD. in Molecular Biology Cell Biology Biotechnology Biochemistry or a related scientific field with 4 years of relevant industry experience; OR
• Masters degree in the fields above with 7 years of relevant industry experience; OR
• Bachelors degree in the fields above with 10 years of relevant industry experience

QUALIFICATIONS:

• Molecular Biology Experience: hands-on expertise in Next-Generation Sequencing (NGS) workflows such as DNA/RNA extraction targeted enrichment or whole genome library preparation and/or deep expertise with other DNA molecular biology techniques such as PCR qPCR and multiplex PCR
• Experimental & Analytical Skills: Ability to own a study from start to finish including designing experiments executing in the lab analyzing data and documenting results. Must be able to perform basic statistical analysis.
• Communication: Excellent cross-functional communication and interpersonal skills with a proven ability to present complex technical data clearly to non-technical audiences
• Execution: Exceptional time management and organizational skills with a demonstrated ability to balance multiple priorities and drive deliverables to completion
• Knowledge of Design Controls Quality Management Systems (QMS) and regulatory standards (FDA ISO 13485 CLSI) within GLP/GMP environments is highly desired
• Experience authoring study plans protocols and study reports is highly desired
• Experience with statistical software (such as JMP) is highly desired
• Prior experience in IVD product development or commercialization is preferred
• Experience in manufacturing scale up and Quality Control (QC) is preferred
• Experience with automated liquid handling platforms (e.g. Hamilton Tecan) is preferred

OUR OPPORTUNITY

Natera is a global leader in cell-free DNA (cfDNA) testing dedicated to oncology womens 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 institutions who care deeply for our work and each other. When you join Natera youll work hard and grow quickly. Working alongside the elite of the industry youll be stretched and challenged and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

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. Other benefits include pregnancy and baby bonding leave 401k benefits commuter benefits and much more. We also offer a generous employee referral program!

For more information visit .

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. Inclusive collaboration benefits our employees our community and our patients and is critical to our mission of changing the management of disease worldwide.

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. We also consider qualified applicants regardless of criminal histories consistent with applicable laws.

If you are based in California we encourage you to read this important information for California residents.

Link: be advised that Natera will reach out to candidates with a @ domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page