location_0_addressRegionName

location_0_addressCountryName

OFFSITE

UNKNOWN

jobPosting hiringOrganization as json hashed.

ADAPTED_NOW

Scientist

You will work cross-functionally with Research & Development teams, automation and process engineering, computational science, and clinical operations to develop and transfer NGS-based assays in a regulated, high-throughput environment. Build productive working relationships and collaborate with engineers and clinical laboratory members to transition development protocols into clinical production, including automation, validation experiments, and SOP development.

KBSkills

ACTIVE

Why join Freenome?Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning. Founded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.  At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.Become a FreenomerDo you have what it takes to be a Freenomer? A “Freenomer” is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients’ lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what’s possible, one breakthrough at a time.About this opportunity: At Freenome, we are seeking an Associate Development Scientist to help grow our Genomics Assay  Development team. At Freenome, you will help develop the assay technologies used to analyze patient samples and contribute to our mission of early cancer detection. The ideal candidate will work to develop assay technologies for our multiomic platform manually and on robotic platforms. You will develop, characterize, verify, and validate clinical-grade assays to measure complex, blood-based analytes (e.g., whole-genome sequencing of cfDNA). You will work cross-functionally with Research & Development teams, automation and process engineering, computational science, and clinical operations to develop and transfer NGS-based assays in a regulated, high-throughput environment. You are passionate about developing life saving diagnostics using NGS technologies, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer. This role reports to the Manager of Genomics Late Stage Development. This role will be an onsite role based in our Brisbane, California headquarters.  What you’ll do:<ul><li>Apply knowledge of molecular biology, nucleic-acid biochemistry, and next-generation sequencing to develop assays for DNA, including genome-wide and targeted approaches</li><li>Participate in experimental design and independently plan and execute mission-critical experiments to optimize and characterize assay performance</li><li>Create and manipulate high impact assay inputs, including use of biological samples and formulation of contrived samples and reagents as required</li><li>Gather high-quality data, take detailed notes, and openly communicate on lessons learned while performing experiments</li><li>Perform data analysis, create summary presentations, and present results cross-functionally</li><li>Perform technical troubleshooting, identify and implement process improvements across the lab by thinking critically about the execution of all experiments</li><li>Build productive working relationships and collaborate with engineers and clinical laboratory members to transition development protocols into clinical production, including automation, validation experiments, and SOP development</li><li>Contribute to writing study protocols and reports. Diligently apply current Good Laboratory and Documentation Practices (cGLP, cGDP) </li></ul>Must haves:<ul><li>Bachelor’s or Master’s degree in molecular biology, biochemistry, genetics, or a related field with at least 5 years of professional experience in the life sciences. Prior experience in clinical diagnostics and/or working in a start-up environment is preferred </li><li>Experience designing and/or executing verification and validation studies for IVD assays in a regulated laboratory environment (GLP)</li><li>Hands-on experience in Next-gen sequencing (NGS) based automated assay development including extraction, library preparation, target capture, and sequencing </li><li>Hands-on experience in nucleic acid preparation, amplification, and quantification (DNA/RNA extraction and purification, PCR, qPCR, ddPCR, Qubit, Fragment Analyzer, Tapestation)</li><li>Experience in working with ctDNA/cfDNA as an analyte in NGS workflows</li><li>Proven track record of designing, planning, and executing successful experiments, interpreting results, preparing data for review, and giving effective scientific presentations</li><li>Experience with automated platforms in plate-based, low-volume formats and/or microfluidics and experience working with automated liquid handlers</li><li>High attention to detail and ability to record accurate and detailed observations, assess impact, and perform troubleshooting as required</li><li>Ability to perform data analysis and to be critical of results obtained during experimentation</li><li>Ability to manually pipette with high confidence, accuracy, and precision</li><li>Clear and proactive communication skills and ability to collaborate effectively with team members in the same and adjacent disciplines</li><li>Flexible and highly motivated to learn new skills and comfortable adapting to changing priorities </li></ul>Nice to haves:<ul><li>Experience in working with with methylated ctDNA/cfDNA as an analyte in NGS workflows</li><li>Familiarity with programing in a scientific programming language (e.g., Python or R) </li></ul>Benefits and additional information:The US target range of our base salary rate for new hires is $104,975 - $159,500. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ <a href="http://freenome.com/job-openings/" rel="no-follow nofollow noopener noreferrer" target="_blank">freenome.com/job-openings/</a> for additional company information.  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.  <ul><li><a href="https://www.dol.gov/agencies/whd/posters/fmla" rel="no-follow nofollow noopener noreferrer" target="_blank">Family & Medical Leave Act (FMLA)</a></li><li><a href="https://www.dol.gov/agencies/ofccp/posters" rel="no-follow nofollow noopener noreferrer" target="_blank">Equal Employment Opportunity (EEO)</a></li><li><a href="https://www.dol.gov/agencies/whd/posters/employee-polygraph-protection-act" rel="no-follow nofollow noopener noreferrer" target="_blank">Employee Polygraph Protection Act (EPPA)</a></li></ul>#LI-Onsite

Freenome

Associate Development Scientist

salaryMin

salaryMax

payPeriod

currency

Assay Development

Assays

Automation

Biochemistry

Biology

Biotech and Pharmaceutical

Cancer

Clinical Laboratory

Clinical Practices/Protocols

Colorectal Cancer

Communication Skills

Computational Engineering

Cross-Functional

Data Analysis

Data Quality

Design Verification

Detail Oriented

Disease

Droplet Digital PCR (ddPCR)

Drug Development

Experiment Design

GLP (Good Laboratory Practices)

Genetics

Genomics

High Throughput

Identify Issues

Machine Learning

Molecular Biology

Next Generation Sequencing (NGS)

Nucleic Acid

Phlebotomy

Polymerase Chain Reaction (PCR)

Problem Solving Skills

Process Engineering

Process Improvement

Programming Languages

Python Programming/Scripting Language

R Programming Language

Real-time PCR (qPCR)

Research & Development (R&D)

Research Protocols

Specimen Analysis

Standard Operating Procedures (SOP)

Startup

Team Player

Test Plan/Schedule

Validation Testing

BioSpace

Services Engineer

This person is responsible for all things related to ensure Laboratory Equipment Lifecycle Management processes (onboarding equipment, IQ, OQ, PQ, calibration, maintenance, pFMEA, decommission) are to adhere to regulatory requirements, on large, fully automated laboratory systems and testing platforms, utilized in our cancer diagnostic test(s). Experience and knowledge in providing laboratory equipment support for Clinical and R&D environments for Hamilton and Bravo Liquid Handlers, Illumina Sequencers, and various other ancillary laboratory instrumentation.

Why join Freenome?Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning. Founded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.  At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.About this opportunity: At Freenome, we are seeking an Automation Service Engineer I/II to help grow the Freenome Automation Service team. The ideal candidate is responsible for providing world-class Laboratory Equipment Lifecycle Management service and support, while contributing to efficient processes, procedures, and best practices. You will have the opportunity to join a fast-growing automation service group, to make an immediate impact on the team’s dynamic and culture. This person is responsible for all things related to ensure Laboratory Equipment Lifecycle Management processes (onboarding equipment, IQ, OQ, PQ, calibration, maintenance, pFMEA, decommission) are to adhere to regulatory requirements, on large, fully automated laboratory systems and testing platforms, utilized in our cancer diagnostic test(s). We are rapidly growing and defining the laboratory systems and processes, so the ideal candidate will be someone who has had experience, not only maintaining service processes, but also scaling them to meet our future needs. You are passionate about changing the world through a product that has the potential to better the standard of care for all current, future and potential cancer patients and you will have a significant impact on the continued growth of a high profile technology organization that is changing the landscape on early cancer detection. The role reports to the Manager, Automation Service.What you’ll do:<ul><li>Perform and support equipment installations, qualifications, scheduled and unscheduled maintenance activities, to ensure the highest level of instrument reliability and up-time </li><li>Support end-users to troubleshoot equipment related issues and failure modes </li><li>Responsible for instrument up-time and ensuring that service documentation meets Freenome’s Quality Management System (QMS) </li><li>Support and update laboratory equipment asset management inventory </li><li>Communicate and coordinate equipment status and updates with internal customers </li><li>Ability to quickly learn new technologies and disseminate information by developing/reviewing SOPs, WIs, Maintenance Forms, checklists, and service bulletins </li><li>Contribute to the management of a maintenance and calibration (CMMS) system </li><li>Develop, implement, and perform Preventative Maintenance (PM) checks and verifications for critical equipment and workcells </li><li>Perform Clinical Lab equipment routine maintenance activities </li><li>Effectively communicate with third party service providers (vendor management) </li><li>Support and manage temperature monitoring system for cold storages and room temperature/humidity setup, configuration, etc. </li><li>Ensure accuracy, completeness, and GMP compliance in laboratory documentation, as it pertains to Equipment Lifecycle Management </li><li>Author, update, and/or revision of laboratory equipment SOPs, WIs, Maintenance Forms, training, technical specifications, etc. (Laboratory Equipment focused Technical Writer) </li><li>Continuous audit of laboratory equipment inventory for accuracy to align with regulatory compliance </li><li>Support 5S spare parts inventory management to support scale and operations </li><li>Experience working within a highly regulated laboratory environment </li></ul>Must haves:<ul><li>B.S. degree in an engineering or scientific discipline, with a minimum of 0-3 years of related industry experience</li><li>Minimum of 0-3 years service engineering or instrumentation and equipment support</li><li>Experience and knowledge in providing laboratory equipment support for Clinical and R&D environments for Hamilton and Bravo Liquid Handlers, Illumina Sequencers, and various other ancillary laboratory instrumentation</li><li>Ability to effectively communicate and collaborate with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines</li><li>Excellent communication skills to work with high dynamic cross functional teams</li><li>Team player: strong communication, collaboration, active listening, and problem-solving skills</li></ul>Nice to haves:<ul><li>Proficient in providing service support for Hamilton and Bravo Robotic liquid handlers</li><li>Experience providing service support for various other laboratory instrumentation</li><li>Familiarity with developing and executing training programs and providing knowledge-transfer to other engineers and lab personnel</li><li>Experience authoring and supporting laboratory equipment PM, IQ, OQ, PQ, repair, and other service related documentation</li><li>Experience working within a CLIA, CAP, PMA, and/or GDP, GMP highly regulated environment</li><li>Experience standardizing processes for scalability and sustainability</li><li>A problem solver with skills and knowledge to work hands on and lead by example</li><li>Hands-on technical troubleshooting skills in high throughput, sample processing laboratories to support operations and scale activities</li><li>Experience utilizing 5S, Lean Manufacturing, and Six Sigma methodologies</li><li>Liquid Handler programming experience is a plus</li></ul>Additional information:Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ <a href="http://freenome.com/job-openings/" rel="no-follow nofollow noopener noreferrer" target="_blank">freenome.com/job-openings/</a> for additional company information.  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.  <ul><li><a href="https://www.dol.gov/agencies/whd/posters/fmla" rel="no-follow nofollow noopener noreferrer" target="_blank">Family & Medical Leave Act (FMLA)</a></li><li><a href="https://www.dol.gov/agencies/ofccp/posters" rel="no-follow nofollow noopener noreferrer" target="_blank">Equal Employment Opportunity (EEO)</a></li><li><a href="https://www.dol.gov/agencies/whd/posters/employee-polygraph-protection-act" rel="no-follow nofollow noopener noreferrer" target="_blank">Employee Polygraph Protection Act (EPPA)</a></li></ul>#LI- Onsite

Automation Service Engineer I (Contractor)

Asset Management

Best Practices

Calibration

Clinical Support

Computerized Maintenance Management System (CMMS)

Diversity

Documentation

Equipment Maintenance/Repair

GMP (Good Manufacturing Practices)

Help Desk

Instrumentation

Instrumentation Engineering

Inventory Management

Knowledge Transfer

Laboratory Equipment

Laboratory Management

Laboratory Operations

Laboratory Systems

Laboratory Testing

Lean Manufacturing

Lean Six Sigma

Legal

Maintenance Services

Onboarding

Operational Support

Preventative Maintenance

Process Failure Mode and Effects Analysis (PFMEA)

Process Validation

Quality Management

Regulations

Regulatory Compliance

Regulatory Requirements

Sample/Specimen Processing

Sequencers

Standards of Care

Sustainability

System Test

Systems Administration/Management

Technical Writing

Training Program Development

Vendor/Supplier Management

Writing Skills

Director Program Management

Develop, track, and analyze the project’s key performance indicators (KPIs), including the effectiveness of technical strategies, regulatory pathways, clinical development progress, project execution, and product development risks (adherence to schedule, scope, resources), to provide management detailed status updates. Enable proactive communication in collaboration with functional directors and managers to assure integration of project, company, and functional goals towards achieving project milestones and timetables.

Why join Freenome?Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning. Founded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.  At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.Become a FreenomerDo you have what it takes to be a Freenomer? A “Freenomer” is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients’ lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what’s possible, one breakthrough at a time.About this opportunity: The Director, Program Management is responsible for planning and driving the execution of primary clinical product development programs for the company. This responsibility extends to overseeing the series of R&D initiatives, lab operations projects, and business-critical initiatives as dependencies of the program. You will serve as a functional manager for the new product initiative program managers and ensure the team’s framework and principles as a center of excellence for the broader organization.The role reports to the Senior Director of Program Management. This role will be a Hybrid role based in our Brisbane, California headquarters. What you’ll do:Drive Strategic Programs and Projects:<ul><li>Responsible for driving the cross-functional In Vitro Diagnostic (IVD) product development programs</li><li>Maintain a sustainable balance of workload and resources to deliver executive-level program status, decision trade-offs, or priorities to senior executive leadership </li><li>Ownership over the list of dependent projects needed to deliver against integrated, detailed plans within budget and timelines by highlighting trade-offs and co-dependencies to meet overall goals and timelines</li><li>Enable proactive communication in collaboration with functional directors and managers to assure integration of project, company, and functional goals towards achieving project milestones and timetables </li><li>Develop, track, and analyze the project’s key performance indicators (KPIs), including the effectiveness of technical strategies, regulatory pathways, clinical development progress, project execution, and product development risks (adherence to schedule, scope, resources), to provide management detailed status updates </li><li>Maintain oversight of all phases of the product development process (PDP) from Concept to Launch. Understanding of Design Control principles and managing gate-keeping, design freezes, design reviews, change control, sign-offs, etc. </li><li>Organize regular team meetings to drive progress, track and mitigate risks, resolve/escalate issues, and review action items </li><li>Generate the necessary documentation and assist teams with creating project plans, protocols, reports, etc. </li></ul>Team and Skill Development:<ul><li>Lead a sustainable program function and cross-functional training to coach and partner with functions on the use of Project Management methodologies </li><li>Recruit, train, manage and develop a diverse team of Program Managers, who can each lead individual project teams to success and growth within the organization </li><li>Implement training and best practices for the Program Management team, introduce process excellence across the organization to improve overall performance and empowerment of teams</li></ul>Must haves:<ul><li>Undergraduate degree in molecular biology, genetics, or closely related field, advanced degree preferred </li><li>At least eight years of experience in medical diagnostics or biotech </li><li>At least five years of program management experience with at least three years in a management or leadership role </li><li>Experience leading the development of IVDs and interactions with FDA - Center of Devices and Radiological Health (CDRH) regulators/reviewers </li><li>Direct experience with laboratory testing or clinical study operations from a diagnostics perspective </li><li>Solid understanding of systems biology or computational biology, ideally cancer biology </li><li>Demonstrated track record of excelling in a process-driven function </li><li>Demonstration of measurably improving organizational success and processes </li><li>Demonstration of leading complex trade-off decisions between functions </li><li>Experience leading the development of decision frameworks and approaches to drive prioritization </li><li>Demonstrated success in presenting to executive-level audiences to facilitate decision making </li></ul>Nice to haves:<ul><li>Systems engineering, bioengineering, or regulated software development experience for healthcare or medical devices </li><li>Certification or formal training in Program Management and experience using resource management tools </li></ul>Benefits and additional information:The US target range of our base salary/hourly rate for new hires is $197,200.00 - $304,000.00. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ <a href="http://freenome.com/job-openings/" rel="no-follow nofollow noopener noreferrer" target="_blank">freenome.com/job-openings/</a> for additional company information.  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.  <ul><li><a href="https://www.dol.gov/agencies/whd/posters/fmla" rel="no-follow nofollow noopener noreferrer" target="_blank">Family & Medical Leave Act (FMLA)</a></li><li><a href="https://www.dol.gov/agencies/ofccp/posters" rel="no-follow nofollow noopener noreferrer" target="_blank">Equal Employment Opportunity (EEO)</a></li><li><a href="https://www.dol.gov/agencies/whd/posters/employee-polygraph-protection-act" rel="no-follow nofollow noopener noreferrer" target="_blank">Employee Polygraph Protection Act (EPPA)</a></li></ul>#LI- Hybrid

Director, Program Management

Bioengineering

Budget Management

Change Control

Clinical Trial

Coaching

Establish Priorities

FDA (Food and Drug Administration)

Healthcare Software

Laboratory

Leadership

Medical Diagnosis

Medical Equipment

Medical Products

Organizational Development/Management

Performance Management

Performance Metrics

Plan Meetings

Product Development

Product Programs

Project Evaluation

Project Execution

Project Planning

Project/Program Management

Resource Management

Risk Management

Software Development

Systems Engineering

Team Lead/Manager

Technical Strategy

Training Program

Quality Assurance Specialist

Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. The ideal candidate will be engaged in supporting the development of the QMS and ensuring compliance based on US FDA Regulations 21 CFR § 820, ISO 13485:2016, in addition to CLIA, CAP, and NYSDOH guidelines.

Why join Freenome?Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning. Founded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.  At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.Become a FreenomerDo you have what it takes to be a Freenomer? A “Freenomer” is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients’ lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what’s possible, one breakthrough at a time.About this opportunity: At Freenome, we are seeking a Quality Assurance Specialist II to help grow the Freenome Quality team. This position will support general QMS compliance activities such as batch record review, supplier management, nonconformances and CAPA. The ideal candidate will be engaged in supporting the development of the QMS and ensuring compliance based on US FDA Regulations 21 CFR § 820, ISO 13485:2016, in addition to CLIA, CAP, and NYSDOH guidelines.The role reports to the Director, Quality Systems.This role will be an onsite role based in our Brisbane, California headquarters. What you’ll do:<ul><li>Review batch records and Device History Records to ensure completeness and compliance, and disposition product accordingly</li><li>Collaborate with QC and other functional areas to resolve errors and document nonconformities</li><li>Author and revise SOPs</li><li>Participate in regulatory inspections/audits and support inspection readiness activities</li><li>Assist in performing internal audits and supplier audits</li><li>Support the Nonconformance and CAPA systems including reviewing, processing, and approving records</li><li>Assist in root cause investigations</li><li>Work with QA management to develop KPIs and support the management review process</li><li>Support QMS improvement and implementation activities</li></ul>Must haves:<ul><li>BS/BA in a life science, engineering, or equivalent discipline; a combination of education and experience will be considered</li><li>3+ years of QA experience in an FDA regulated industry, preferably Medical Device or IVD</li><li>Ability to work effectively in a collaborative team environment</li><li>Ability to adapt to changing priorities, manage multiple competing priorities with aggressive timelines within a fast-paced environment</li><li>Attention to detail and commitment to Quality at every stage of the product life cycle</li><li>Self-driven, ability to work under minimal supervision</li><li>Excellent written and verbal communication</li><li>Critical and analytical thinking, ability to assess risks and benefits, and develop effective solutions</li></ul>Nice to haves:<ul><li>Quality Certifications (e.g., CQA, Six Sigma, ISO 13485 Lead Auditor, etc.)</li><li>Experience using electronic Quality Management Systems</li></ul>Benefits and additional information:The US target range of our base salary for new hires is $81,175 - $123,500. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ <a href="http://freenome.com/job-openings/" rel="no-follow nofollow noopener noreferrer" target="_blank">freenome.com/job-openings/</a> for additional company information.  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.  <ul><li><a href="https://www.dol.gov/agencies/whd/posters/fmla" rel="no-follow nofollow noopener noreferrer" target="_blank">Family & Medical Leave Act (FMLA)</a></li><li><a href="https://www.dol.gov/agencies/ofccp/posters" rel="no-follow nofollow noopener noreferrer" target="_blank">Equal Employment Opportunity (EEO)</a></li><li><a href="https://www.dol.gov/agencies/whd/posters/employee-polygraph-protection-act" rel="no-follow nofollow noopener noreferrer" target="_blank">Employee Polygraph Protection Act (EPPA)</a></li></ul>#LI-HYBRID

Quality Specialist II

Analysis Skills

Auditing

Code of Federal Regulations

Corrective and Preventative Action (CAPA) Systems

FDA Requirements

ISO (International Organization for Standardization)

Internal Audit

Maintain Compliance

Multitasking

Presentation/Verbal Skills

Product Lifecycle

Quality Assurance

Quality Control

Risk Analysis

Root Cause Analysis

Six Sigma

Vendor/Supplier Evaluation

Systems Administrator

As the primary administrator and escalation point for our lab systems, this person must possess strong technical and communication skills with the ability to anticipate, triage and resolve problems quickly, maintain impeccable systems uptime and deliver measurable IT value to the business. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education.

Why join Freenome?Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning. Founded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.  At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.Become a FreenomerDo you have what it takes to be a Freenomer? A “Freenomer” is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients’ lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what’s possible, one breakthrough at a time.About this opportunity: The Senior Systems Administrator will be responsible for the technical design, planning, implementation and day-to-day administration of our lab IT systems. The ideal candidate will have strong skills and experience in managing windows environments, plus a strong understanding of server, storage, and networking technologies. This individual will build and maintain highly-resilient, secure and scalable IT solutions for our fast-growing labs. As the primary administrator and escalation point for our lab systems, this person must possess strong technical and communication skills with the ability to anticipate, triage and resolve problems quickly, maintain impeccable systems uptime and deliver measurable IT value to the business. This opportunity is suited to proactive and detail-oriented IT professionals with a broad set of technology skills and experience. If your experience is a fit, then don't miss out on joining us at Freenome where we're revolutionizing early cancer detection through advanced technology products and services.  The role reports to the Senior Manager, IT Infrastructure. This role will be a Hybrid role based in our Brisbane, California headquarters.  What you’ll do:<ul><li>Design, maintain and troubleshoot hardware/software solutions to support our labs which develop and conduct groundbreaking diagnostic tests for cancer</li><li>Own and maintain system imaging, software deployment, and patch management infrastructure</li><li>Install and manage lab related software and licenses </li><li>Deploy and manage Windows machines (physical and virtual) </li><li>Manage and maintain Windows servers </li><li>Collaborate with other various team members and departments to develop and maintain solutions in a regulated environment </li><li>Build and maintain close relationships with key stakeholders  </li><li>Provide primary support for lab IT computers, infrastructure, and systems issues/requests, and ensure all IT incidents and requests are prioritized and resolved in a timely and professional manner within SLA guidelines </li><li>Install and maintain systems firmware, software and patches/utilities on lab machines. Schedule after-hours maintenance and engage vendors for support and warranty repairs as appropriate</li><li>Plan, communicate, and deploy changes to Lab IT systems per standard change management process and scheduled maintenance windows. Coordinate IT change and maintenance activities with business stakeholders </li><li>Create and maintain standard IT policies, procedures, and user guides for lab environment </li><li>Follow established IT policies, procedures, and controls to ensure compliance with applicable laws and regulations </li><li>Maintain and enforce security across all lab systems and applications from core to edge </li></ul> Must haves:<ul><li>10+ years of experience in hands-on support and troubleshooting Windows in a corporate environment</li><li>10+ years of experience managing Windows PC</li><li>7+ years of experience in managing Windows Servers</li><li>7+ years of experience in managing Active Directory, DNS, DHCP</li><li>3+ years of experience with MDM Solutions</li><li>Strong knowledge and experience with PowerShell</li><li>Strong knowledge and understanding of network, server, storage, and virtualization technologies</li><li>Strong knowledge with industry current computing hardware and peripherals</li><li>Strong knowledge of security access controls, policies, groups, rights, and permissions</li><li>Highly efficient in time management, adept at multitasking to support lab operations, fulfill core responsibilities, and manage multiple projects simultaneously</li><li>Skilled in documenting and clearly explaining complex technical solutions to both management and non-technical staff</li><li>Strong customer service and time management skills, with the ability to work effectively in a dynamic, and fast-paced environment</li><li>Flexibility to work weekends and after hours for IT projects/maintenance (on occasion)</li></ul>Nice to haves:<ul><li>Bachelor's degree in MIS/CIS, Computer Science or equivalent professional experience </li><li>Efficient in one or more of the following: Azure Management Tools, Pulumi, Terraform, Python,  </li><li>Efficient in one or more flavors of Linux </li><li>Experience with IP Management Solutions (DDI Efficient IP)  </li><li>Industry certifications such as ITIL, CCNA, MCITP, MCSA, MCSE, VCP, Cloud+, Security+ preferred </li><li>Familiarity with IT GRC (BCDR, ITSM/ITIL, GMP, GDPR, FDA 21 CFR Part 11) </li><li>Experience in diagnostic labs is a plus </li></ul>Benefits and additional information:The US target range of our base salary for new hires is $131,325 - $201,000. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ <a href="http://freenome.com/job-openings/" rel="no-follow nofollow noopener noreferrer" target="_blank">freenome.com/job-openings/</a> for additional company information.  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.  <ul><li><a href="https://www.dol.gov/agencies/whd/posters/fmla" rel="no-follow nofollow noopener noreferrer" target="_blank">Family & Medical Leave Act (FMLA)</a></li><li><a href="https://www.dol.gov/agencies/ofccp/posters" rel="no-follow nofollow noopener noreferrer" target="_blank">Equal Employment Opportunity (EEO)</a></li><li><a href="https://www.dol.gov/agencies/whd/posters/employee-polygraph-protection-act" rel="no-follow nofollow noopener noreferrer" target="_blank">Employee Polygraph Protection Act (EPPA)</a></li></ul>#LI- Hybrid

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