Manager, Quality Control

Freenome
South San Francisco, CA Full Time
POSTED ON 1/11/2022 CLOSED ON 4/14/2022

Job Posting for Manager, Quality Control at Freenome

About Freenome 

At Freenome, we’ve developed a multiomics platform to detect cancer at the earliest stages using a routine blood test. Our team is a dedicated and driven group of experts who believe that by making our tests accurate, easy and accessible, we can change the entire landscape of cancer care. 

About the Role

As the Manager 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 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.

Your contribution:

  • 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.
  • 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

Your background, perspective and experience: 

  • Minimum 5 years of industry laboratory setting OR biochemical and molecular assays
  • Minimum 2 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

Freenome’s contribution: 

  • Competitive compensation 
  • Pre-IPO equity
  • Flexible PTO (exempt) and generous PTO (non-exempt) 
  • Comprehensive health coverage, including medical, dental, and vision 
  • Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
  • 401(k) plan 
  • $250.00 new hire stipend to enhance your home office experience
  • Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts 

Freenome has adopted a COVID-19 vaccination policy to safeguard the health and well-being of our employees. As a condition of employment, our employees working on-site are required to be fully vaccinated for COVID-19, unless a reasonable accommodation is approved or as otherwise required by law.

 

About Our Science

We’re 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 from thousands of prospective samples. 

By developing novel statistical learning methods and applying them to integrate various -omics datasets, we’ve become a leader in modeling specific biological mechanisms. This means we’re capturing 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, we’re learning the biological changes present in the blood during different stages of cancer. 

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. 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, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

  • Family & Medical Leave Act (FMLA)
  • Equal Employment Opportunity (EEO)
  • Employee Polygraph Protection Act (EPPA)

Notice to agencies:

Our in-house Talent Acquisition Team manages all employment opportunities at Freenome.  Agencies and independent recruiters must be approved as a vendor by Freenome’s Talent Acquisition team before submitting candidates to any Freenome employee. 

We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. 

Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you.

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Job openings at Freenome

Freenome
Hired Organization Address South San Francisco, CA Full Time
Why join Freenome? Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood dr...
Freenome
Hired Organization Address South San Francisco, CA Full Time
Why join Freenome? Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood dr...
Freenome
Hired Organization Address South San Francisco, CA Full Time
Why join Freenome? Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood dr...
Freenome
Hired Organization Address South San Francisco, CA Full Time
Why join Freenome? Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood dr...

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