Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Company
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Aurora, Colorado.
About the Role
The Automation Engineer at Foresight Diagnostics will be responsible for supporting the development of and owning maintenance for Foresight’s laboratory automation function. As the business life cycle evolves to vertically integrate manufacturing, this role will take point in development and implementation with transition to the tech transfer functions within the organization. This position will collaborate cross functionally to deliver on business objectives with the intention of cross functional integration and operational scaling. This is a full-time position working standard business hours, but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the Director of Clinical Laboratory Operations.
Responsibilities
Effectively deliver to project deadlines, on time and on budget, with adherence to applicable quality and regulatory requirements.
Iterate on processes to drive continuous improvement with prioritization managed through the application/interpretation of KPI results.
Collaborate with laboratory leads to align on automation requirements and develop workflows and instrument methods for laboratory optimization and software integration.
Develop SOPs to enable successful tech transfer of technology to the laboratory teams for production use.
Work cross-functionally with Operations, Finance, and laboratory teams as necessary to properly forecast the number of automation instrumentation needed to meet volume demand, plan for and propose upgrades to the Foresight’s automation solution, and perform maintenance to ensure operational capacity never impacts Foresight’s ability to successfully deliver on time results.
Collaborate with Research to identify manufacturing requirements for vertically integrated products, develop manufacturing processes and QC metrics to enable successful tech transfer of technology to the Reagent Manufacturing and QC teams for production use.
Ensure effective resource utilization, planning and execution of people, process, and products in alignment with corporate objectives and volume projections across cross-functional teams.
Implement laboratory processes that are compliant with appropriate regulations, to include but not limited to GxP, ISO, CFR, CAP/CLIA, NYSDOH.
Guide troubleshooting and resolution of incident reports and CAPAs while driving continuous improvement.
Skills and Qualifications
5+ years engineering experience supporting laboratory environments.
A bachelor’s degree: BA/BS. An advanced degree, such as a Ph.D. or Masters degree preferred.
Additional technical training would be a plus with an understanding of molecular biology and genomics.
Working knowledge of liquid handling platforms such as Hamilton Star line and Agilent Bravo preferred
Proven ability to deliver actionable results to complex problems.
Strong organizational skills with an understanding of scaling and capacity planning.
Advanced analytical and operational skills with an ability to identify meaningful insights from complex data.
Self-starter who thrives in ambiguity in a fast-paced environment.
Ability to deliver on end-to-end projects with a high level of autonomy.
This role is offering a salary between $118,000-140,000, and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
About our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role: As a Bioinformatics Analyst, you will be responsible for analyzing sequencing data to deliver clinical diagnostic results to internal and external stakeholders. You will maintain and improve existing workflows, while developing new workflows to support the growing needs of the company. This position will work directly with the operations, science and engineering organizations, with opportunities to grow in all three domains and their intersections. This position requires a high level of organization and attention to detail. This position has flexibility for fully onsite, hybrid or remote work; if hired as remote worker, quarterly travel to our headquarters in Colorado is expected.
What You Will Bring:
What You Will Do:
This role is offering a salary between $75,000-100,000 and is eligible for equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024.
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
About our Company
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role
This role will support the planning and execution of clinical trials, including biopharma partnerships and Foresight-sponsored studies. This role will work collaboratively with Medical Affairs, Quality Assurance, Regulatory Affairs, the Production clinical laboratory, and data analytics as well as with external stakeholders such as the biopharma partners and CROs. This is a hybrid position, although fully remote is acceptable. Periodic travel may be required.
Responsibilities
Support clinical data management activities for biopharma partnerships, Foresight-sponsored studies (prospective and retrospective), investigator-initiated trials, and other analytical needs as required.
Develop and maintain data management documentation, including data management plans, relevant portions of study protocols, case report forms (CRF), and CRF completion guidelines.
Develop data transfer file requirements and templates for exchange of clinical data, MRD testing data, and biospecimen manifests.
Perform data cleaning activities, including discrepancy management and query resolution for prospective data collection and dataset for retrospective studies.
Data aggregation and internal database development for storage of laboratory and testing data related to clinical trial conduct and evaluation of MRD test performance.
Generate and review clinical study dashboards and data summaries for use in tracking study progress, centralized data monitoring, and study reports.
Design case report forms (CRFs), electronic data capture (EDC), and electronic patient-reported outcomes (ePRO) systems for data collection.
Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.
Collaborate with study team members to resolve data-related issues and discrepancies.
Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
Contribute to the development and validation of data management software tools.
Skills and Qualifications
Required
3-5 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry
Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
Proficiency in electronic data capture (EDC) systems and clinical data management software.
Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.
Excellent attention to detail with problem-solving and analytical skills.
Strong organizational and time management abilities.
Preferred
Experience in molecular diagnostics and oncology.
Certification in clinical data management (like CCDM).
Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).
Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
This role is offering a salary between $90,000-105,000, and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Location: Boulder, Colorado, United States
About our Company:
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role
The Clinical Laboratory Scientist II will be responsible for performing a variety of laboratory procedures involved in end-to-end processing of biological samples to enable successful downstream next-generation sequencing (NGS). Processing will include accessioning and both manual and automated extraction, library preparation, hybrid capture, sequencing and QC steps. Under the guidance of the Director of Clinical Laboratory Operations and the Laboratory Director, you will work collaboratively within the clinical laboratory leveraging your technical knowledge, skills and abilities to ensure efficient and quality results are provided to our clients and patients while also informing/participating in process improvements. This position will report to the Director of Clinical Laboratory Operations.
Responsibilities
Technical
Perform routine and complex diagnostic laboratory testing on patient samples for clinical, biopharma, and academic partnerships.
Provide technical guidance and oversight to non-licensed personnel for pre-analytical, analytical and post-analytical activities.
Interpret data and results of all analyses according to set procedures and guidelines.
Support day to day operations by assisting with data entry, receiving samples and consumables, reagent preparation, sample preparation, temperature recording, laboratory maintenance and documentation.
Identify and resolve problems that may adversely affect test performance or reporting of test results following the escalation path to clinical leadership as needed.
Assist with research, translational research, regulated products through the execution of partnership studies and internal/external validation studies.
Participate as a contributing member of the clinical laboratory by assisting in routine activities, to include but not limited to general upkeep and stocking, SOP author and review, and continuous improvement.
Proposes assay and process improvements and conducts improvement activities under guidance.
Demonstrate forward thinking and initiative in work planning and execution of work in order to achieve on-time report delivery.
Participate in new or revised assay launches giving input on launch logistics as appropriate.
Participate in work planning initiatives and scheduling.
Quality, Training & Equipment
Maintaining documentation in compliance with Good Laboratory Practices and Quality Systems.
Assist with quality control and quality assurance activities. Responsible for reviewing and analyzing the health of laboratory quality metrics in collaboration with clinical leadership.
Complete initial training and maintain competencies as current and up to date for all trained assays.
Wear appropriate PPE as required and comply with safety rules and regulations.
Follow standard operating procedures (SOP).
Participate in IQ/OQ/PQ for equipment to ensure ability to train team members on proper use and maintenance as appropriate.
Escalate equipment issues that impact TAT or patient safety.
Assist, perform, and review instrument correlation studies. Collaborate with operational leadership on equipment analysis for assay expansion or improvement.
Perform instrument and procedural calibrations and maintenance.
Advises and drives progress on troubleshooting equipment issues.
Adhere to the laboratory's quality control policies including document control activities, change management, corrective preventative action.
May act as trainer in place of designated trainer/training team.
Team
Cultivate, build and maintain positive and collaborative relationships within teams and cross-functionally.
Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific and performance standards to ensure the highest quality for sample integrity.
Seen as a role model for safety behavior standards and cultural tenets.
Serves as a leader from the bench, demonstrating consistency in good lab practices.
Knowledge, Skills and Abilities
Bachelor’s or Master's degree in chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution
Education received at a college or university located outside of the United States or United States Territories requires a credentials equivalency evaluation by an approved agency
Hold a current and active American Society of Clinical Pathology (ASCP) board certification
Hold current and valid Clinical Laboratory Scientist licensure (Generalist or CGMBS)
Demonstrate a working knowledge of the general biological principles that govern DNA biology
Possess a strong foundational understanding of common molecular biology techniques, such as PCR/qPCR, DNA ligation, and DNA extraction
Working level knowledge or ability to learn use of common molecular biology instruments; Agilent Tapestation/capillary electrophoresis, Qubit, plate readers, thermocyclers and other common laboratory instruments
Experience with implementing and performing histology processes, preferred
Previous experience handling human biological materials is required
Working knowledge of how to safely operate in a BSL-2 environment is required
Previous experience handling, processing, and extracting DNA from biological specimens is required
Working Conditions and Physical Effort
Staff in this role must be able to perform the essential functions of the job with or without a reasonable accommodation. Certain physical activities may be required in order to perform the essential functions of this job. Examples of these requirements include but are not limited to the following:
This role is offering an hourly wage between $49.28 - 54.09 and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024.
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Location: Boulder, Colorado, United States
About our Company:
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role
The Clinical Laboratory Scientist III will be responsible for performing a variety of laboratory procedures involved in end-to-end processing of biological samples to enable successful downstream next-generation sequencing (NGS). Processing will include accessioning and both manual and automated extraction, library preparation, hybrid capture, sequencing and QC steps. Under the guidance of the Director of Clinical Laboratory Operations and the Laboratory Director, you will work collaboratively within the clinical laboratory leveraging your technical knowledge, skills and abilities to ensure efficient and quality results are provided to our clients and patients. The Clinical Laboratory Scientist III will also inform and participate in process improvements through ownership and leadership. This position will report to the Director of Clinical Laboratory Operations.
Responsibilities
Technical
Perform routine and complex diagnostic laboratory testing on patient samples for clinical, biopharma, and academic partnerships.
Provide technical guidance and oversight to licensed and non-licensed personnel for pre-analytical, analytical and post-analytical activities.
Interpret data and results of all analyses according to set procedures and guidelines.
Support day to day operations by assisting with data entry, receiving samples and consumables, reagent preparation, sample preparation, temperature recording, laboratory maintenance and documentation.
Identify and resolve problems that may adversely affect test performance or reporting of test results following the escalation path to clinical leadership as needed.
Assist with research, translational research, regulated products through the execution of partnership studies and internal/external validation studies.
Participate as a contributing member of the clinical laboratory by assisting in routine activities, to include but not limited to general upkeep and stocking, SOP author and review, and continuous improvement.
Proposes assay and process improvements and conducts improvement activities under guidance.
Demonstrate forward thinking and initiative in work planning and execution of work in order to achieve on-time report delivery.
Participate in new or revised assay launches giving input on launch logistics as appropriate.
Participate in work planning initiatives and scheduling.
Utilize understanding of d/pFMEA, failure modes and phenotypes for the assay chemistry and instrumentation to support risk assessment and remediation.
Author standard operating procedures (SOPs), process maps, decision trees, and/or training program materials to facilitate successful implementation of instrumentation into the clinical laboratory testing workflow.
May operate as a General Supervisor.
Quality, Training & Equipment
Maintaining documentation in compliance with Good Laboratory Practices and Quality Systems.
Assist with quality control and quality assurance activities. Responsible for reviewing and analyzing the health of laboratory quality metrics in collaboration with clinical leadership.
Complete initial training and maintain competencies as current and up to date for all trained assays.
Wear appropriate PPE as required and comply with safety rules and regulations.
Follow standard operating procedures (SOP).
Participate in IQ/OQ/PQ for equipment to ensure ability to train team members on proper use and maintenance as appropriate.
Escalate equipment issues that impact TAT or patient safety.
Assist, perform, and review instrument correlation studies. Collaborate with operational leadership on equipment analysis for assay expansion or improvement.
Perform instrument and procedural calibrations and maintenance.
Advises and drives progress on troubleshooting equipment issues.
Adhere to the laboratory's quality control policies including document control activities, change management, corrective preventative action.
Train internal clinical team to new instrumentation, products, processes, or assays to support successful implementation in the clinical laboratory.
Team
Cultivate, build and maintain positive and collaborative relationships within teams and cross-functionally.
Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific and performance standards to ensure the highest quality for sample integrity.
Seen as a role model for safety behavior standards and cultural tenets.
Serves as a leader from the bench, demonstrating consistency in good lab practices.
Knowledge, Skills and Abilities
6+ years of relevant laboratory work experience
2+ years Experience in ISO 13485/15189, GLP and or CAP/CLIA environments
Bachelor’s or Master's degree in chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution
Education received at a college or university located outside of the United States or United States Territories requires a credentials equivalency evaluation by an approved agency
Hold a current and active American Society of Clinical Pathology (ASCP) board certification
Hold current and valid Clinical Laboratory Scientist licensure (Generalist or CGMBS)
Experience performing complex molecular biology workflows, ideally NGS workflows
Experience with implementing and performing histology processes, preferred
Previous experience designing and performing validations and verifications, process development and process-directed documentation
Experience in complex problem-solving and risk management/mitigation (i.e. identify potential equipment or chemistry failures)
Working Conditions and Physical Effort
Staff in this role must be able to perform the essential functions of the job with or without a reasonable accommodation. Certain physical activities may be required in order to perform the essential functions of this job. Examples of these requirements include but are not limited to the following:
This role is offering an hourly wage between $51.44 - 59.38 and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024.
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
About the Company
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role
This role will support the planning and execution of clinical trials, including biopharma partnerships and Foresight-sponsored studies. This role will work collaboratively with Medical Affairs, Quality Assurance, Regulatory Affairs, and the Production clinical laboratory as well as with external stakeholders such as the biopharma partners, clinical research organizations, clinical investigators, and ethics committees. This position is a hybrid preferred, but fully remote will be considered. Periodic travel may be required.
Responsibilities
Manage contract and/or full-time clinical research associate(s).
Plan and execute clinical trial readiness activities for biopharma partnership clinical trials, including phase I-III and biomarker qualification studies.
Oversee and execute clinical operations activities related to laboratory testing for biopharma partnerships, including:
In-house monitoring of source and laboratory data
Manage and resolve biospecimen or data issues with Sponsor, CRO, or other study partners
Monitor and report adverse device effects
Oversee and execute clinical operations activities for prospective, sponsored trials, including:
Site and trial-level budget development
Site feasibility evaluation and site activation
Oversight of trial conduct, including monitoring
Site and trial close-out
Oversee and execute IRB submissions and applicable regulatory submissions (e.g. adverse device event reporting)
Oversee TMF set-up and maintenance for all new and on-going studies
Maintain and update clinical operations documents that govern trial conduct
Skills and Qualifications
Certification in Good Clinical Practice and Human Subjects Research
At least 5 years of experience in Clinical Operations
Experience building and managing a team
Experience in molecular diagnostics and oncology preferred
Excellent written and verbal communication skills
Detail-oriented and able to manage multiple projects at the same time
Proficiency in Microsoft products
Strong strategic thinking and problem-solving skills
This role is offering a salary between $180,000-205,000 and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
About the Company
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role
The Histotechnologist will be responsible for assisting Foresight in standing up the histology laboratory and for processing all specimens received under minimal supervision. This position will partner with the Laboratory Director, laboratory operations leadership, research and development, and medical affairs/clinical operations to select and implement methodologies and instrumentation utilized in processing tissue specimens. The Histotechnologist will also be cross trained to support processing of clinical and translational research samples from accessioning through sequencing. Under the guidance of the Senior Manager, Production Laboratory, you will work collaboratively within the production laboratory leveraging your technical knowledge, skills, and abilities to ensure efficient and quality results are provided to our clients and patients. The Histotechnologist will also inform and participate in process improvements through ownership and leadership. This position will report to the Senior Manager, Production Laboratory.
Responsibilities
Operations
Perform routine and complex histology and laboratory testing on patient samples for clinical, biopharma, and academic partnerships.
Provide technical guidance and training, as needed, to production personnel on histological processing of specimens to include methodology, instrumentation, staining, maintenance, waste disposal, etc.
Support histology integration with Foresight’s LIMS as the technical SME for histology
Collaborate with cross functional teams to stand up Foresight’s histology laboratory and support research and development of new products requiring histology.
Interpret data and results of all analyses according to set procedures and guidelines.
Support day to day operations by assisting with data entry, receiving samples and consumables, reagent preparation, sample preparation, temperature recording, laboratory maintenance and documentation.
Identify and resolve problems that may adversely affect test performance or reporting of test results following the escalation path to production leadership as needed.
Assist with research, translational research, and regulated products through the execution of partnership studies and internal/external validation studies.
Participate as a contributing member of the production laboratory by assisting in routine activities, to include but not limited to general upkeep and stocking, SOP author and review, and continuous improvement.
Propose assay and process improvements and conduct improvement activities under guidance.
Demonstrate forward thinking and initiative in work planning and execution of work in order to achieve on-time report delivery.
Participate in new or revised assay launches giving input on launch logistics as appropriate.
Participate in work planning initiatives and scheduling.
Author standard operating procedures (SOPs), process maps, decision trees, and/or training program materials to facilitate successful implementation of instrumentation into the clinical laboratory testing workflow.
Perform and interpret special stains and immunohistochemistry procedures.
Maintain accurate and detailed records of all tests performed, including any deviations from standard procedures.
Collaborate with pathologists to review and interpret tissue samples.
Implement and adhere to laboratory safety protocols to ensure a safe working environment.
Quality, Training & Equipment
Maintain documentation in compliance with Good Laboratory Practices and Quality Systems.
Assist with quality control and quality assurance activities. Responsible for reviewing and analyzing the health of laboratory quality metrics in collaboration with production and clinical operations leadership.
Complete initial training and maintain competencies as current and up to date for all trained assays.
Wear appropriate PPE as required and comply with safety rules and regulations.
Follow standard operating procedures (SOP).
Participate in IQ/OQ/PQ for equipment to ensure the ability to train team members on proper use and maintenance as appropriate.
Escalate equipment issues that impact TAT or patient safety.
Assist, perform, and review instrument correlation studies. Collaborate with operational leadership on equipment analysis for assay expansion or improvement.
Perform instrument and procedural calibrations and maintenance.
Advise and drive progress on troubleshooting equipment issues.
Adhere to the laboratory's quality control policies including document control activities, change management, and corrective preventative action.
Train internal production team to new instrumentation, products, processes, or assays to support successful implementation in the histology laboratory.
Team
Cultivate, build, and maintain positive and collaborative relationships within teams and cross-functionally.
Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific, and performance standards to ensure the highest quality for sample integrity.
Seen as a role model for safety behavior standards and cultural tenets.
Serve as a leader from the bench, demonstrating consistency in good lab practices.
Knowledge, Skills and Abilities
6+ years of relevant laboratory work experience.
2+ years of experience in ISO 13485/15189, GLP and or CAP/CLIA environments
Bachelor’s or Master's degree in chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution.
Education received at a college or university located outside of the United States or United States Territories requires a credentials equivalency evaluation by an approved agency.
Hold a current and active American Society of Clinical Pathology (ASCP) board certification.
Hold current and valid Histotechnician (HT) or Histotechnologist (HTL) certification.
Experience performing complex molecular biology workflows.
Previous experience designing and performing validations and verifications, process development and process-directed documentation.
Experience in complex problem-solving and risk management/mitigation (i.e. identify potential equipment or chemistry failures).
Working Conditions and Physical Effort
Staff in this role must be able to perform the essential functions of the job with or without a reasonable accommodation. Certain physical activities may be required in order to perform the essential functions of this job. Examples of these requirements include but are not limited to the following:
Strength & Endurance
Standing, Walking Sitting
Pushing and Pulling
Crouching, Stooping & Kneeling
Lifting
2 hour increments
40 lbs
Coordination
Manual Dexterity
Tactile Sensitivity
Repetitive movement
Communication & Vision
Verbal Communication
Written Communication
Color Vision
Depth Perception
This role is offering an hourly rate between $29.75 - $34.50, and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
About the Company:
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role
We are seeking a talented Sapio LIMS Administrator to join our growing team. In this role, you will be responsible for the day-to-day administration, maintenance, and support of our Sapio Laboratory Information Management System (LIMS).
Responsibilities:
System Administration:
Manage user accounts and access permissions within Sapio LIMS.
Configure and maintain system settings to optimize performance and meet user needs.
Support system backups and disaster recovery procedures.
Stay up-to-date on Sapio LIMS updates and implement them effectively.
Data Management:
Ensure data integrity and compliance with relevant quality standards (e.g., GxP, FDA).
Manage and maintain master data (samples, instruments, methods, etc.) within Sapio LIMS.
Generate reports and analyze data to support laboratory operations.
User Support:
Provide technical support to scientists and researchers using Sapio LIMS.
Train users on new features and functionalities of the system.
Troubleshoot user issues and resolve problems efficiently.
Develop and maintain user documentation for Sapio LIMS.
Other Responsibilities:
Collaborate with laboratory staff and IT department to ensure seamless integration of Sapio LIMS with other systems.
Stay informed about industry best practices for LIMS administration.
Qualifications:
Bachelor's degree in Science, Information Technology, or a related field (or equivalent experience).
2+ years of experience administering a LIMS system (preferably Sapio LIMS).
Strong understanding of laboratory workflows and data management principles.
Excellent analytical and problem-solving skills.
Experience with user support and training methodologies.
Proficient in computer software and comfortable working in a technical environment.
Excellent communication and interpersonal skills.
A meticulous attention to detail and a commitment to data accuracy.
This role is offering a salary between $85,000-100,000, and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
About the Company
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role
The Reagent Manufacturing QC Specialist will be responsible for supporting daily operations for Foresight’s reagent manufacturing to supply the research, development and production laboratories with materials required to perform testing. This position will follow and maintain processes and documentation in compliance with regulations appropriate for the intended use of the materials (i.e. CLIA, ISO). This position will work cross functionally with internal members of the R&D, Production, Bioinformatics, and Supply Chain and Procurement teams. This is a full-time position working standard business hours, but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the Reagent Manufacturing & QC Lead/Manager.
Responsibilities
Coordinate with cross functional teams on daily and weekly planning to ensure materials and volumes are available to support timely execution of regulatory studies, research, translational medicine, and clinical testing
Support developing processes for manufacture, quarantine, verify and release of reagents for research and clinical testing needs in compliance with appropriate regulations
Create, maintain and conduct annual reviews of reagent manufacturing and QC SOP and batch records
Perform and review QC testing according to work instructions and batch records
Work with cross functional laboratory leads, supply chain, and quality to develop and maintain a process to receive, test, and release reagents to production inventory
Ensure traceability of reagents by following Foresight’s established SOP for lot number assignment and record-keeping
Bring technical issues to leadership and present solutions, when possible
Collaborate with Supply Chain, R&D, and Production to establish a reagent manufacturing schedule based on forecasted quarterly demand
Draft and review validation protocols and reports for reagent manufacturing, as appropriate
Maintain inventory of reagents to support testing needs.
Perform reagent manufacturing day to day operations to meet business objectives without negative impact to cross functional teams, TAT, or quality
Assist in the development, collection, and reporting of performance metrics including critical to quality and continuous improvement metrics for release of materials and biobanking.
Assist in monitoring, maintaining, and improving the efficiency of processes
Other job related duties and projects as assigned.
Skills and Qualifications
2+ years in laboratory environments
A bachelor’s degree: BA/BS.
Hands-on experience in quality control, molecular biology, and/or clinical laboratory testing (NGS preferred) and technical understanding of quality control as it relates to regulated environments.
Strong organizational skills.
Analytical and operational skills with an ability to identify meaningful insights from complex data.
Self-starter who thrives in ambiguity in a fast-paced environment.
Ability to deliver on end-to-end projects with a high level of autonomy.
Exceptional interpersonal skills with ability to work inclusively and collaboratively with a diverse population, both internally and externally.
Model behavior to promote teamwork, professional staff interactions, and a safe work environment.
This role is offering an hourly rate between $25.00-29.25, and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
About our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role: We are seeking a highly experienced and visionary Senior Director of System Engineering to lead our systems engineering team in the design, development, and implementation of our advanced cancer diagnostic systems. The ideal candidate will have a strong background in system engineering, particularly within the molecular diagnostics or medical device industry, and a deep understanding of regulatory requirements, including software regulations. This role is critical in ensuring the integration of software components and data management necessary to deliver robust and compliant diagnostic solutions.
What You Will Bring:
Bachelor’s or Master’s degree in Software Engineering, Biomedical Engineering, or a related field.
Minimum of 6 years of experience in system engineering within the molecular diagnostics, medical device or related industry.
Proven track record of leading engineering teams and managing complex projects.
Deep understanding of regulatory requirements, including CLIA, FDA, ISO 13485, 21 CFR Part 820, and IEC 62304.
Strong knowledge of system design, integration, and validation processes.
Excellent leadership, communication, and interpersonal skills.
Ability to thrive in a fast-paced, dynamic environment.
Knowledge of bioinformatics and data analysis tools, a strong plus.
Knowledge and experience medical device cybersecurity, a strong plus
What You Will Do:
Leadership and Strategy:
Lead and mentor a team of engineers, fostering a collaborative and innovative work environment.
Develop and execute the system engineering strategy aligned with the company’s goals and regulatory requirements.
Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Clinical to ensure cohesive product development and operations.
System Design and Development:
Oversee the design, development, and validation of diagnostic systems, ensuring integration of software components and the flow of data.
Ensure systems meet performance, reliability, and scalability requirements.
Lead the architecture and design of system interfaces, data management, and analytical tools.
Software Regulations and Compliance:
Ensure all software components comply with relevant regulatory standards such as FDA’s 21 CFR Part 820 (Quality System Regulation) and IEC 62304 (Medical Device Software Lifecycle Processes).
Lead software validation and verification processes, ensuring documentation and testing meet regulatory requirements.
Collaborate with software and algorithm developers to ensure robust and compliant software design, development, and deployment.
Stay updated with changes in regulatory standards and guide the team in compliance efforts.
Support Software Development and Build Infrastructure:
Develop and maintain a robust software development lifecycle (SDLC) framework tailored to meet the needs of our diagnostic systems.
Oversee the establishment and maintenance of build and release pipelines, ensuring automated, efficient, and reliable software delivery.
Implement and manage tools and processes for continuous integration and continuous deployment (CI/CD).
Troubleshoot and resolve build and deployment issues, working closely with software developers and testers.
Continuous Improvement:
Drive continuous improvement initiatives to enhance system performance, reliability, and compliance.
Foster a culture of innovation and quality within the engineering team.
Evaluate and implement new technologies and methodologies to maintain a competitive edge.
This role is offering a salary between $225,000-265,000 and is eligible for equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024.
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
About the Company
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role
The Senior Manager, Production Laboratory at Foresight Diagnostics plays a pivotal role in overseeing the daily operations of our Production laboratory; supporting both clinical and translational research functions. Reporting directly to the Site Lead, this position is responsible for managing personnel, optimizing workflows, ensuring compliance with regulatory standards, and fostering a culture of excellence and innovation within the laboratory environment. The Senior Manager, Production Laboratory will collaborate closely with cross-functional teams to drive operational efficiency and uphold the highest standards of quality in cancer diagnostics. A successful candidate will possess a strong blend of technical expertise, leadership skills, regulatory knowledge, and practical experience in laboratory operations. This is a full-time onsite position with the possibility of flexible working hours, including evenings, weekends, and holidays, as needed to support laboratory operations.
Responsibilities
Operational Management: Overseeing day-to-day laboratory operations, including testing procedures and result reporting, to ensure timely and accurate delivery of results.
Personnel Management: Recruiting, hiring, training, and supervising testing production laboratory staff, as well as providing ongoing support, coaching, and performance evaluation.
Leadership: Operate as a Change Ambassador facilitating implementation of strategic and operational decisions that enable execution of corporate objectives and goals.
Workflow Optimization: In concert with the Site Lead, developing and implementing efficient laboratory workflows and protocols to maximize productivity, minimize turnaround times, and optimize resource utilization.
Cross functional Partnership: Participate in and drive cross functional communication, planning, and execution strategies to enable streamlined clinical and translational research testing operations and advancements with the goal of improved outcomes for patients and clients.
Quality Assurance and Compliance: In collaboration with the Laboratory Director and the Site Lead, ensure compliance with regulatory standards, including CLIA, CAP, FDA, GxP and other applicable regulations, by maintaining accurate records, performing quality control procedures, and participating in proficiency testing programs.
Instrumentation and Equipment Management: Overseeing the day to day maintenance, calibration, and troubleshooting of laboratory instruments and equipment to ensure optimal performance and reliability. Serve as the first line of defense when issues impacting operations occur.
Inventory Management: In collaboration with the Supply Chain department, support management of laboratory supplies, reagents, and consumables inventory to ensure adequate stock levels, minimize waste, and prevent delays in testing.
Safety and Environmental Management: Implementing and enforcing safety protocols, procedures, and regulations to protect laboratory staff, patients, and the environment from potential hazards and ensure compliance with OSHA and other safety standards.
Customer Service and Communication: Interfacing with external partners to address inquiries, provide support, and ensure a high level of clinical and translational research customer satisfaction.
Continuous Improvement: Identifying and escalating opportunities for process improvement, quality enhancement, and cost optimization through ongoing evaluation, benchmarking, and implementation of best practices.
Training and Education: Providing ongoing training, education, and professional development opportunities for laboratory staff to enhance their skills, knowledge, and performance.
Wet Lab Testing: Maintain proficiency in wet lab processes to provide testing support, if/when needed and to ensure quality and efficacy of laboratory training programs.
Emergency Response and Crisis Management: Developing and implementing contingency plans and protocols to address emergencies, equipment failures, or other unforeseen events that may impact laboratory operations or patient care.
This position has direct supervisory responsibilities.
Skills and Qualifications
Bachelor's degree (BA/BS) in a relevant scientific field such as biology, chemistry, medical technology, laboratory management or a related discipline required; advanced degree (Ph.D. or Masters) preferred. Certification as a Medical Laboratory Scientist (MLS), Clinical Laboratory Scientist (CLS), or equivalent certification preferred.
Minimum of 5 years of experience in people leadership roles within laboratory and operations environments.
Excellent leadership, team management, and interpersonal skills with the demonstrated ability to lead and manage a diverse team of laboratory professionals, influence cross functional teams, and operate as a change champion.
Demonstrated ability to build rapport with cross functional leaders to enable delivery to shared goals and objectives.
Proficiency in a wide range of laboratory techniques and procedures relevant to high complexity testing, including molecular biology and chemistry.
Experience with the operation, maintenance, and troubleshooting of laboratory instruments and equipment used for high complexity testing.
Knowledge of quality control principles and practices, including the implementation and interpretation of quality control procedures, proficiency testing, and documentation requirements
Ability to analyze and interpret laboratory data, identify trends or deviations, and take appropriate corrective actions as needed.
Understanding of CLIA regulations and guidelines, ISO15189, as well as other relevant regulatory requirements such as FDA regulations, Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) requirements.
Demonstrated ability to lead and manage a diverse team of laboratory professionals, including hiring, training, performance management, and fostering a culture of collaboration and excellence.
Excellent organizational skills with experience in laboratory workflow optimization.
Ability to implement strategic plans, goals, and objectives for the laboratory, aligning with the organization's mission and objectives.
Self-starter with the ability to thrive in a fast-paced, ambiguous environment and deliver projects autonomously.
This role is offering a salary between $125,000-140,000 and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Location: Boulder, Colorado, United States - Hybrid
About our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role: We are seeking a highly experienced and visionary leader to lead our DART (Data, Algorithms, Research and Technology) team in the design, development, implementation and execution of our advanced cancer diagnostic products and algorithms. The ideal candidate will have a strong background in leading multi-disciplinary teams including, software engineering, bioinformatics, systems engineering, particularly within the molecular diagnostics or medical device industry. This role is responsible for the development of both the medical device software and internal lab-supporting tools, such as Laboratory Information Management Systems (LIMS) and data management tools.
What You Will Bring:
Bachelor’s or Master’s degree in Software Engineering, Bioinformatics, or a related field.
Minimum of 10 years of experience in software engineering and/or bioinformatics with a focus on algorithm development and medical device software.
Minimum of 5 years of experience leading teams with increasing scope of responsibility.
Proven track record of delivering complex software projects
Understanding of regulatory requirements and quality standards for medical device software.
Strong knowledge of system design, integration, and validation processes.
Excellent leadership, communication, and interpersonal skills.
Ability to thrive in a fast-paced, dynamic environment.
Knowledge of laboratory information management systems (LIMS) and data management tools, a plus.
What You Will Do:
Leadership and Strategy:
Lead, mentor, and manage a diverse team of software engineers, bioinformaticians, and system engineers.
Develop and execute the strategic vision for algorithm development and software engineering.
Support the development and growth of cross functional teams and leaders through education and development initiatives
Collaborate with executive leadership to align software development initiatives with overall business objectives.
Evaluate "build versus buy" decisions to determine the most efficient and cost-effective approach for project completion.
Allocate resources effectively to balance workload and meet project deadlines.
Software and Algorithm Development:
Oversee the development and implementation of internal lab-supporting tools, including LIMS and data management systems.
Lead the design and development of advanced algorithms to support bioinformatics and medical device functionality.
Drive the development of robust, scalable, and secure medical device software in compliance with industry standards and regulations.
Ensure the integration and interoperability of software systems across various platforms and products.
Collaborate with cross-functional teams to translate clinical and scientific requirements into innovative algorithmic solutions.
Quality & Compliance:
Ensure all software products meet regulatory requirements and quality standards.
Oversee the documentation of software development processes, including requirements, design specifications, testing, and validation.
Innovation & Continuous Improvement:
Stay abreast of emerging technologies and industry trends to drive innovation within the team.
Foster a culture of continuous improvement, encouraging team members to develop new skills and explore novel approaches.
This role is offering a salary between $250,000-295,000 and is eligible for equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024.
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.