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Director, Quality Control

Organization

Freenome

Job Location

279 East Grand Avenue
5th Floor
South San Francisco, CA 94080
United States

Job Description

About the Role

As the Director of Quality Control you will join a highly collaborative team and make an immediate impact on early cancer detection.  You will support Freenome’s mission by establishing a quality control organization within Laboratory Operations and build a team that will leverage both internal and external capabilities to enable QC testing needs for Freenome's multiomics IVD including continuous improvements. The high complexity nature of the work demands an in-depth understanding of reagent and consumable QC testing, analytical methods, statistical analysis and technology, and regulatory requirements. The work requires keeping meticulous and organized records, excellent attention to detail, the ability to prioritize and be flexible with multiple tasks and schedules.

How you’ll contribute:

  • Establish a quality control organization within Laboratory Operations and build a team that will leverage both internal and external capabilities to enable both routine and unique QC testing needs for Freenome’s multiomics IVD including continuous improvements. 
  • Collaborate with the development team to develop Quality Control strategy and direction on new and existing analytical methods and provide support for verification, validation and transfer activities. 
  • Responsible for investigation and resolution of reagent/consumable-related issues , including impact assessment, root cause analysis, and implementation of corrective and preventive actions and continual monitoring of its effectiveness.
  • Responsible for ensuring reagent and consumable testing is performed and analyzed according to established manufacturing and incoming QC work instructions.
  • Draft, review and update reagent quality control  documentation (SOP, batch records, work instructions, test methods, etc.) and any planned or unplanned deviations.
  • Ensure consistent compliance with applicable federal, state and local regulations and quality-related best practices in development, validation, use, and documentation of analytical and functional test methods for reagent lot qualification, stability studies, and related activities.
  • Review and manage stability studies, validation protocols, other process improvements, and new assay projects
  • Responsible for supporting the development, implementation, and continual improvement of quality control aspects of the quality management system. 
  • Provide support in audits, including vendor qualification audits, and self inspections of quality control areas. 
  • Control and manage Quality Control budget including preparation, monitoring and adherence to Freenome’s strategy.
  • Hire, mentor, motivate, and provide direction to the Quality Control team
  • Ensure the environment for employees is safe from physical, chemical, and biological hazards, and that safety and biohazard requirements are followed and is responsible for reporting all quality and safety concerns to the Laboratory Director or Safety Officer.

What you’ll bring: 

  • Minimum 10 years of industry laboratory setting OR biochemical and molecular assays
  • Minimum 3 years of leadership or mentorship experience in reagent manufacturing and/or quality control
  • Masters or Bachelor in chemical, physical, biological science, or related field
  • Proficient in a variety of basic, intermediate, and advanced laboratory skills
  • Proficient with NGS or multiplex protein assays and demonstrated ability to analyze and problem solve complex issues impacting reagent performance
  • Comprehensive knowledge of Current Good Manufacturing Practices (CGMP), ISO 13485, 21 CFR part 820, and other medical device (IVD) regulations in addition to working knowledge of local, state, and federal laboratory regulations
  • Strong communicator with ability to maintain open communication with internal employees, managers, and customers as needed
  • Ability to prioritize and drive to results with a high emphasis on quality
  • Ability to work as part of a cross functional team
  • Ability to provide direct supervision to the QC team
  • Strong analysis, including process statistics,  and problem-solving skills
  • Strong technical skills and job and industry knowledge
  • Ability to proactively communicate consistently, clearly, and honestly
  • Strong automation, computing skills, and project management abilities

 

How to Apply

Apply Here

About Our Organization

About Freenome

Freenome is on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent cancer.

We have pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw.  By combining deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, we are developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science. 

Our recent $270 Million Series C brings our financing to over $500 million from investors, including;  Bain Capital, Perceptive Advisors, RA Capital, Polaris Partners, Andreessen Horowitz, funds and accounts advised by T. Rowe Price Associates, Inc., GV (formerly Google Ventures), Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Data Collective Venture Capital, Novartis and Verily Life Sciences. 

Our Science

Freenome is building technology to advance the understanding of cancer through multiple analytes derived from blood. These signals include cell-free DNA, methylation of cell-free DNA, cell-free RNA, circulating proteins, and immune profiling derived from thousands of prospective samples. By developing novel statistical learning methods and applying them to integrate various -omics datasets, Freenome is a leader in modeling specific biological mechanisms to capture disease-dependent signatures, including gene expression, immune response, tumor burden, the tissue of origin, and 3D chromatin structure. 

By building comprehensive discovery datasets and modeling critical biological systems, Freenome is learning what biological changes are present within the blood between a variety of different disease states, including cancer, autoimmune disorders, infections, drug response, and aging. The synthesis of Freenome’s datasets, cross-functional technical expertise, and audacious mission to discover biological truth, we seek to improve the lives of millions through early detection and early treatment of disease.  

Our Culture

Freenomers are technical, creative, visionary, grounded, empathetic, and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time. 

We value empathy, integrity, and trust in one another, and we respect the diverse perspectives of our colleagues and those we serve.  We assume positive intent and give each other the benefit of the doubt with the firm belief that we are a team working toward the same objectives.  We believe in empowering and supporting each other in a collaborative and dynamic environment. 

What does a successful person look like at Freenome?

Those who thrive at Freenome prioritize, manage, and execute their own goals with ownership and alignment with those of the company. They embrace our values of empathy, integrity, striving for greatness, servant leadership, trust, and holding themselves and their team accountable to these values. They crave collaboration with brilliant minds from disparate fields of study and believe that hiring and mentorship are fundamental to our success. Above all, they welcome and provide constructive feedback and criticism, trusting in others’ good intentions, and being secure in knowing that embracing mistakes is the best way to learn and grow. For those who pursue challenges, understudied problems, and want the opportunity to see their work impact the lives of millions of people affected by cancer every year, there’s no better place to be than Freenome.

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.

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