Manager QC Development

Manager, QC Development is responsible for modifying existing methods and/or developing and optimizing new QC methods to support routine lot release of reagents and kits used in the CLIA laboratory. Provides technical and scientific operations support in event of deviations and/or non-conformance issues arising for reagent preparation and/or qualification.  

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  Primary responsibilities include leading a team responsible for development and optimization of reagent Quality Control (QC) Tests and associated bio-chemical process optimizations to support routine reagent and kit qualification. 

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  Analyze data and prepare documentation for QC method validation, author and revise QC testing SOPs and reports to ensure the successful implementation of assays in the laboratory.

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  Oversee technical transfer of new product QC methods from Research and Development into Operations, addressing process development needs for implementation. 

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  Provide technical and scientific operations support in event of deviations and/or non-conformance issues arising for reagent preparation and/or qualification to ensure disposition(s) for impacted material(s) are driven by scientifically rational input.

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  Personnel management includes: provide technical assistance, employee development, coaching and counseling, administering performance appraisals, and enforcing company policies through appropriate disciplinary measures  

• Ph.D. in Molecular Biology, related field, or equivalent.

• Minimum of 4 years of experience in Industry.

• Previous management experience required.

• Previous experience working in Assay Development or QC lab is highly desired.

• CLIA/FDA laboratory support experience is a plus.  

• Leadership and functional management experience of medium sized group.

• Ability to prioritize responsibilities in a high pace environment.

• Strong technical expertise in molecular biology and NGS based laboratory assays.

• Strong reagents and quality control management and development.

• Extant technical writing skill is strongly preferred.

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 institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.