Manager QC Development

Regulatory Toolkit; 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

Position Summary

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.

Primary Responsibilities

• 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.
• 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.
• Oversee technical transfer of new product QC methods from Research and Development 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

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.

Knowledge, Skills, and Abilities

• 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.

Compensation & Total Rewards

This range reflects a good-faith estimate of the base pay we reasonablyexpect to offer at the time of hire.Final compensation will vary based on experience, qualifications, and internal equity considerations.

This positionis also eligible for additional compensation and benefits throughNatera’s robust Total Rewards program, including:

• Annual performance incentive bonus
• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Additional wellness and work-life benefits

Compensation Range

$139,600—$208,500 USD

OUR OPPORTUNITY

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.

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!

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.

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

Link: https://www.natera.com/notice-of-data-collection-california-residents/