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.
Location: Boulder, Colorado, United States
Schedule: Multiple shifts Monday through Saturday between 8 am and 8 pm
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.
What You Will Bring:
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
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
What You Will Do:
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.
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 April 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
Schedule: Multiple shifts Monday through Saturday between 8 am and 8 pm
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.
What You Will Bring:
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
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)
What You Will Do:
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.
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 April 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: Remote in the 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 Director, Business Development is responsible for business development activities for Foresight Dx and is accountable for revenue generation from biopharma partners and research institutions. Foresight Dx customers are biopharmaceutical companies or research institutions seeking precision oncology assays to evaluate MRD and a partner to execute diagnostic projects to enable regulatory filings. This individual also will monitor execution of some contracted work to ensure quality and provide a high level of customer satisfaction.
What You Will Bring:
Bachelor's Degree
Combined 5 years business development and sales experience selling a complex product or service
Previous experience in a healthcare products company (therapy, diagnostics or medical devices)
Proven track record in achieving company goals through creation of strategic partnerships, including pre-contract negotiations and post-contract alliance management.
Experience with the establishment of contracts, development of pricing strategies and monitoring contract fulfillment.
Preferred:
Bachelor’s Degree in a life sciences discipline
Master of Business Administration or a relevant life sciences PhD
Prior corporate development, tactical and/or strategic marketing experience
Previous experience in the companion diagnostics field or biopharma partnering
What You Will Do:
Lead business development for a portfolio of current and potential biopharma partners, including contract and in some cases alliance management activities for customers located potentially globally.
Create objectives and key results as well as account strategies needed to close revenue generating contracts for customers ranging from biopharma companies to research institutions.
Partner with marketing to support the voice of the customer for all marketing activities. Ensure strong handoff from marketing efforts to generate awareness in Foresight Dx and belief in Foresight Dx solutions to business development activities to reach and secure new customers.
Develop, maintain and execute a strong pipeline of new business and qualified leads.
Maintain a good understanding of the trends in the biopharmaceutical industry and how they impact the Foresight Dx and diagnostics broadly. Additionally, leverage these insights to support the strategic plan of the organization.
Follow emerging business trends and economic requirements of the biopharmaceutical industry as well as screen and recommend key target companies.
Work with project and lab personnel to ensure projects can be fully supported and delivered on quality and time.
Closely collaborate with all functions to align Foresight Dx biopharma partnership activities with the capabilities of the organization.
May manage staff as the business needs grow; provide staff with coaching, training, and opportunities to develop skills, and give ongoing, constructive and timely feedback on performance and progress toward goals and expectations.
Other duties as assigned by management.
This role is offering a salary between $210,000-240,000, 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 April 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.
Work location: On site in 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 IT Support Analyst will support our internal customers with high quality, rapid IT service and help manage on-site employees’ requests for service, workstations, and related infrastructure. In this position, you will be responsible for driving daily support and troubleshooting and expand upon your current technical skill set by joining an existing team. Additionally, you will have the opportunity to continue building your engineering ability solidifying and supporting a cutting edge, growing environment. You will apply technical skills and creativity in support of our scientific research and development for Foresight Diagnostics platforms. This role reports to the Manager, IT Operations.
This role is expected to have a flexible second shift schedule that includes 12-8pm shifts during the week and Saturday.
What you will do:
What you will bring:
Preferred Qualifications and Experience:
This role is offering an hourly wage of $25.25 - 28.85 per hour 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 April 5, 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: Hybrid (on site 3 days per week) in 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: As Foresight has reached new, exciting business milestones, we are starting to build out our Program Management Office (PMO). Foresight’s ideal candidate for the Program Manager role will have experience in both diagnostic program and/or product management and will collaborate cross functionally with internal stakeholders and external partners to deliver multiple projects simultaneously. The Program Manager will own, drive, communicate, and engage all project partners to enable accountability, problem solving, and on time delivery. To successfully execute at this level and with tight timelines, verbal communication and tool implementation, utilization, and management, paired with onsite presence (3 days a week) are critical to our shared success and our ability to deliver on Foresight’s mission.
This is a full-time position working standard business hours, but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. The Program Manager role reports into the SVP, Business and Laboratory Strategy & Operations.
For the ideal candidate needing to relocate for this position, Foresight may provide a sign on bonus to help cover your relocation costs.
What You Will Bring:
5+ years of experience in project/product management, with experience in biotechnology and clinical lab industries including direct experience delivering LDT and IVD products in FDA and CAP/CLIA regulated environments.
Program and product management experience supporting diagnostics, MRD experience preferred.
PMP or other project management certifications preferred.
Proven track record of successfully managing complex projects from initiation to closure and have led projects bringing products to market in a biotechnology environment (diagnostics product experience preferred).
Proficiency in project management tools and software.
Energy, motivation, and flexibility with excellent oral and written communication.
Situational awareness, coupled with facilitation, problem solving, and conflict resolution skills to drive cross-functional decision-making.
Familiarity with design control, translating user needs to product requirements, agile development, SWOT analysis, and product lifecycle management tools.
Ability to manage multiple projects and tasks concurrently with strong attention to timeline and performance metrics.
Demonstrated ability to work in a dynamic fast-paced environment, establish, and meet deadlines for product delivery.
Experience developing complex diagnostics including assay and software components.
Ability to think critically to overcome hurdles and devise solutions.
This position may be required to work across time zones as needed to support project schedules.
What You Will Do:
Technical
Lead project planning and execution, including scope, schedule, budget, and resource management and product design and development, ensuring processes are followed in accordance with regulations and general controls.
Develop project strategy and plans achieving buy-in from leadership and stakeholders.
Communicate project status, issues, and risks to senior leadership and stakeholders.
Ensure stakeholders/team members understand and adhere to project scope, coordinate on process development, implementation, and improvement, efficiently and effectively assess and remediate technical issues, and manage changes through defined change control protocols.
Facilitate and encourage collaboration across departments to ensure projects are completed successfully, within budget and on time.
Develop project and program management tools and
Conduct opportunity and risk management activities including identification, mitigation and realization for assigned projects/programs.
Coordinate with the SVP, Business and Laboratory Strategy & Operations and peers to develop and implement project management policies, procedures, and standards.
Identify opportunities for improvement in portfolio level processes, inform senior leadership of proposed solutions, and collaborate on implementation.
Team
Cultivate, build and maintain positive and collaborative relationships within teams and cross-functionally.
Partner with Alliance Management Team to ensure successful internal and external partner engagement and execution to delivery timelines.
Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific and performance standards.
Foster a culture of continuous improvement, identifying areas for process improvement and implementing changes as appropriate.
This role is offering a salary between $115,000-140,000, 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 April 5, 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: Hybrid near Boulder, Colorado
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 is an exciting opportunity for someone looking for career growth joining at an exciting time for the accounting department and for the Company. This is a newly created position to support a startup that will have a tangible positive impact on society. The Senior Accountant will play a key role in supporting the Controller, managing day-to-day accounting activities (GL/AP/AR), and in building and shaping the accounting function for a startup. This role will demand attention to detail, the willingness to go outside prescriptive job duties, to embrace the unknown, and a healthy obsession for process improvement and compliance.
What You Will Bring:
A roll-up-your sleeves, can-do, positive attitude. A personality to contribute to our start-up culture, but with an eye for proactiveness, compliance, discipline, meeting deadlines, and critical thinking relating to operations and maintaining accurate books.
Bachelor’s degree in business, accounting, or related field.
Minimum of 4+ years’ experience working as an accountant.
CPA and public accounting experience is preferred, but not required.
Previous operations experience in AP, AR, and potentially payroll.
Experience in biotechnology, genomics, or diagnostics industries is advantageous, especially with clinical research/regulated products.
Strong knowledge of US GAAP, internal controls, and risk assessment.
Previous GL involvement in full cycle month-end close activities and financial reporting, including revenue, COGS allocation, etc.
Experience with Netsuite ERP system is preferred but not required.
Proficiency in Microsoft Excel and Word is required.
Ability to juggle competing priorities, meet deadlines, and to proactively communicate priorities.
Ability to maintain confidentiality over all sensitive matters and information.
Ability to collaborate effectively with the Controller and other members both externally and internally to ensure compliance and project success, including a successful first audit.
Contribute to the growth and maturation of the accounting function as the Company expands.
Willingness to perform job duties not entailed in this job description.
What You Will Do:
Set a shining example of professionalism, integrity, and ethical conduct for the Accounting Department, serving as a role model and promoting a positive work culture.
Collaborate closely with the Controller in establishing, managing, and improving upon the month close cycle. Eagerness to be involved in every aspect of the close cycle.
Take ownership in managing the accounts payable and receivable processes, and potentially the payroll process. Own various other day to day compliance activities.
Support audit readiness requirements and operational enhancements for eventual commercialization of Foresight Diagnostic’s assays.
Develop relationships and provide value for key department leaders as well as to meet accounting function requirements.
Contribute to the development of enhanced internal controls.
Assist with process improvement and recommendations for efficiencies and automation while adhering to compliance/GAAP requirements.
Assist with system implementations and integrations, as needed.
Develop a deep understanding of the systems you will work with which will include Netsuite, Bill.com, Salesforce, and Brex.
Adhere to established accounting policies and provide value added feedback to the revision of those policies.
Onboard and steer the development of additional staff members, as needed.
Support business goals as needed. Assist in finance goals such as budget management, cash flow forecasting, as needed.
This role is offering a salary between $93,000-108,000 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 April 5, 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: On site or hybrid schedule in 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 Senior Manager, Quality Assurance will be responsible for establishing and maintaining quality processes and improvement initiatives for FDA and ISO-regulated products and clinical testing, specifically supporting Foresight’s GCP/CLIA laboratory. This role will operationalize quality systems, leveraging your technical knowledge, skill and abilities to ensure regulatory compliance. The Senior Manager, Quality Assurance will also manage internal and external communication with regulatory agencies overseeing the clinical laboratory and ensuring all applications, systems, products and procedures meet defined quality standards. This position will report to the Director of Quality.
What You Will Bring:
Bachelor’s degree in a scientific field
Minimum of 7 years of experience in an FDA/ISO-regulated environment, including experience with Clinical regulations (CAP/CLIA/NYSDOH for high-complexity laboratory testing)
Ability to define, scope, map and implement new or improved documented quality processes
Knowledge of BSL-2 laboratories
Experience with LIMS, eQMS, and paper-based quality systems
Excellent verbal and written communication skills, as well as attention to detail and organizational skills
What You Will Do:
Implement and maintain the necessary programs to support the Quality Policy, the Quality System, and continuous improvement initiatives to ensure compliance with ISO15189, FDA GCP and GLP, CAP/CLIA, NYSDOH, and other US and international regulatory standards.
Ensure that Quality System elements are in compliance with Clinical, ISO, and FDA regulations, and help to create and/or drive improvements to Policies and Standard Operating Procedures.
Oversee FDA-regulated design control activities to ensure effective and compliant execution for the Foresight assay and software design.
Manage design control documentation required for effective DHF/DHR/DMR management.
Organize and lead the management of NCR/CAPA, complaints, management review, laboratory support, services, processes, reporting, supplier management, document and records control, training, audits, and other QMS responsibilities.
Define and maintain quality metrics to measure, analyze, and implement processes to monitor and improve quality.
Identify and evaluate issues and/or gaps in processes and documentation, and propose effective solutions to remediate.
Host and provide front-room representation during internal and external audits, including CAP, FDA, ISO, and biopharmaceutical companies.
Manage audit program, including schedule adherence, reviewing audit reports, and following up on required actions.
Maintain the eQMS and provide document control support.
Team
Communicate and interact with all levels of the organization including Executive Leadership
Work effectively with cross-functional teams for problem-solving, product and process improvement
Cultivate, build and maintain positive and collaborative relationships within the Quality team 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
Leverage leadership skills to motivate, inspire and train staff to engage in quality and adhere to regulations
This role is offering a salary between $155,000-169,000 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 April 5, 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.