Experience in Assay Development or QC lab is highly desired.
CLIA/FDA laboratory support experience is a plus.
Responsibilities
Lead a team in developing and optimizing reagent Quality Control (QC) Tests.
Analyze data and prepare documentation for QC method validation.
Oversee technical transfer of new QC methods from R&D to Operations.
Provide technical support for deviations and non-conformance issues.
Manage personnel through coaching, performance appraisals, and policy enforcement.
Benefits
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
Full 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 reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.
This position is also eligible for additional compensation and benefits through Natera'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
About Natera
Natera is a biotechnology company that focuses on genetic testing and diagnostics. The company's products are designed to help diagnose and treat genetic diseases, cancer, and other conditions. Natera's pipeline includes products for reproductive health, oncology, and organ transplantation. The company was founded in 2003 and is headquartered in San Carlos, California.
