Lead QC Development Manager: Molecular Assays

Regulatory Jobs; San Carlos (CA); On-site; USD 140,000 - 209,000; Full time

Benefits offered by this job

Annual performance bonus

Long-term equity awards

Health benefits

401(k) with company match

Paid time off

Wellness benefits

Job summary

Natera is seeking a Manager, QC Development in California to lead a team focused on developing and optimizing QC tests for reagents and kits used in CLIA laboratory settings. You will drive method validation, SOP documentation, and cross-functional transfers to Operations.

The role emphasizes strong leadership in a fast-paced environment, with responsibilities for technical writing, data analysis, and ensuring rigorous QC standards across assays, with a competitive Total Rewards package.

Qualifications

• 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.

Responsibilities

• Lead a team responsible for development and optimization of QC tests and associated biochemical process optimizations to support routine reagent and kit qualification.
• Analyze data and prepare documentation for QC method validation, author and revise QC testing SOPs and reports to ensure successful implementation of assays in the laboratory.
• Oversee technical transfer of new product QC methods from R&D into Operations, addressing process development needs for implementation.
• 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.
• Personnel management includes: provide technical assistance, employee development, coaching and counseling, administering performance appraisals, and enforcing company policies through appropriate disciplinary measures

Skills

Leadership

Molecular biology

NGS assays

Quality control

Technical writing

Project management

Education

Ph.D. in Molecular Biology

Job description

Natera is seeking a Manager, QC Development in California to lead a team focused on developing and optimizing QC tests for reagents and kits used in CLIA laboratory settings. You will drive method validation, SOP documentation, and cross-functional transfers to Operations.

The role emphasizes strong leadership in a fast-paced environment, with responsibilities for technical writing, data analysis, and ensuring rigorous QC standards across assays, with a competitive Total Rewards package.