Manager QC Development

Natera; San Francisco (CA); On-site; USD 140,000 - 209,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

401(k) with match

Paid time off

Job summary

Natera in San Francisco is seeking a Manager, QC Development to lead a team focused on developing and optimizing QC tests for reagent and kit qualification, and to support routine lot release.

The role requires strong data analysis, SOP authoring, and cross-functional tech transfer from R&D to Operations, with emphasis on leadership and molecular biology/NGS expertise.

Qualifications

• Ph.D. in Molecular Biology, related field, or equivalent.
• Minimum of 4 years of experience in Industry.
• 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 reagent QC tests and bio-chemical process optimizations for routine reagent and kit qualification.
• Analyze data and prepare documentation for QC method validation; author and revise QC testing SOPs and reports.
• Oversee technical transfer of new QC methods from R&D into Operations; address process development needs for implementation.
• Provide technical and scientific operations support for deviations/non-conformance to ensure disposition of impacted materials.

Skills

Leadership

People management

Molecular biology

NGS assays

Technical writing

Prioritization

Education

Ph.D. in Molecular Biology

Job description

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 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

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.

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.

Please be advised that Natera will reach out to candidates with a @ natera.com email 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Natera’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.