Foresight Diagnostics is a cancer diagnostics company developing a novel liquid biopsy test for the measurement of minimal residual disease (MRD) for aid in patient management that is funded by leading diagnostics VC firms in Silicon Valley. Foresight’s cell-free DNA testing platform was developed in the labs of two prominent professors at Stanford University and is backed by several major Cell and Nature publications. The company has garnered significant partnering interest from multiple pharmaceutical companies in oncology and is poised for rapid growth. Foresight Diagnostics is headquartered in Aurora, Colorado.
We are seeking a creative and rigorous Bioinformatician to be a key player in the development of Foresight’s cancer diagnostic workflow. The successful candidate will work within our R&D team to develop and validate cutting-edge cancer diagnostic NGS assays. The successful candidate will have a deep technical understanding of NGS assays and data analysis, strong communication skills, the ability to be flexible with tasks and schedules, and the ability to work well both independently and in a team environment. The primary roles of this position are to:
Support the clinical laboratory operations team by developing and maintaining a robust cloud-based bioinformatic pipeline for the analysis, interpretation, and reporting of results generated in a CLIA regulated environment. The individual will be responsible for communicating the results of this pipeline to both internal and external stakeholders.
Support the R&D assay development team by analyzing and interpreting the results of laboratory experiments and providing feedback on the design of future experiments.
Responsibilities
Architect, build, and operate cloud computing services and environments applying well-established best practices.
Implementation and deployment of production software.
Development of custom bioinformatics pipelines for the analysis of next-generation sequencing data.
Collaborate with R&D scientists to design and analyze data from experiments to assess and improve assay performance.
Participate in brainstorming sessions and collaborative efforts within a highly interactive work environment.
Communicate analysis results to stakeholders across computational and experimental teams.
Requirements
BA or BS (or equivalent) in computational biology, bioinformatics, statistics, computer science, or related fields
Proficiency with Python, R, Bash scripting or similar programming languages.
Experience with git, APIs, and agile software development lifecycle.
Experience leveraging cloud computing services (e.g. GCP or AWS).
Experience visualizing complex experiments to derive biological insights.
Excellent written and verbal communication skills.
Dedicated to making a difference in a rapid-paced startup environment.
Preferred Experience
MS or Ph.D. in computational biology, bioinformatics, genomics, statistics, computer science, or related fields.
Background in molecular biology and/or cancer biology.
Prior Industry Experience.
Experience developing next-generation sequencing data pipelines.
Experience with standard NGS bioinformatics tools (e.g. Samtools, Bedtools, BWA, etc.).
Experience building and deploying containers in a microservices architecture.
Ability to write queries in SQL and experience maintaining/using PostgreSQL or similar database.
Compensation
We offer highly competitive salary and benefits combined with a generous equity package. 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.
The Head of Operations at Foresight Diagnostics (specific title to be determined based on experience) will lead and participate in the global operations of the business to ensure that the CLIA laboratory and client experience is exemplary. Additionally, this role has the opportunity to be customer facing with pharmaceutical and biotechnology partners. The successful candidate will be a hands-on leader who will manage the CLIA certified laboratory and team.
Responsibilities
Support the business in delivering world-class cancer diagnostics data to customers on time and on budget.
Lead the design, execution, and report generation for analytical validation studies.
Manage and scale day to day operations in the lab to ensure project timelines and quality objectives are met. Responsibilities include logistics, supply chain and chain of custody control, inventory and reagent management.
Selection, implementation and ongoing maintenance of laboratory software systems, including eQMS, LIMS, inventory management, e-lab notebooks.
Develop and deploy the strategy for ongoing platform automation and scaling of molecular biology workflows to increase throughput and decrease turnaround time.
Develop, expand & lead the operations team.
Requirements
BA/BS in Molecular Biology, Biochemistry, or a related life science field.
7+ years of experience in the life sciences or biotechnology industry.
Experience in the operations and launch of novel complex diagnostics into growing markets; managing to timelines.
Past experience in working with and managing multiple outside vendors and Pharmaceutical Partners, including internationally.
Demonstrated ability to recruit quality talent and lead high performing teams.
Proven experience in scaling operations from early stage to higher demands due to significant growth.
Experience interfacing with regulatory bodies.
Understanding of companion diagnostics and LDTs.
Solid knowledge of cancer diagnostic product development.
Ability to operate cross functionally at multiple levels of the organization; effective at managing relationships with direct reports, peers and the Board and CEO.
Preferred Experience
Advanced degree (Ph.D, MD, or MS) in Molecular Biology, Biochemistry, or a related life science field.
Prior experience in working in a startup environment.
Experience with Illumina’s NGS instrumentation equipment (NovaSeq).
A technical background is highly preferred for this role, with an understanding of molecular biology and genomics.
Understanding of database implementation and management.
Compensation
We offer highly competitive salary and benefits combined with a generous equity package. 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.
The Manager of Quality Management Systems, is a strategic position reporting to the CEO, responsible for the development, implementation, and maintenance of the Quality Program including Quality Assurance (QA), the Quality Management System (QMS), and supplier quality to ensure compliance with relevant ISO standards and FDA regulations such as ISO 13485:2016 and ISO 14971:2012.
Functions include management, oversight and monitoring of CAPA, Complaints, Management Review, Document and Records Control, Training, and Internal Audit. Assure that relevant procedures are managed and continuously reviewed and improved for compliance and operating efficiencies.
Responsibilities
Implement and maintain the necessary programs to support the Corporate Quality Policy, the Quality System, and Continuous Improvement initiatives as they relate to the QMS.
Build strong quality systems for determining the appropriate infrastructure and resources required for department to achieve business objectives.
Assume responsibilities for the Quality Management System (software design life cycle, assay design control, production support, supplier approval process including audits, complaints, document control, training program, etc.)
Develop quality performance indicators.
Support hosting internal and external audits, review audit reports, and follow up on required actions.
Organize, oversee and lead management of CAPA, Complaints, Management Review, Document and Records Control, Training and Internal Audit, approving plans and expenditures necessary to achieve objectives.
Perform other duties as assigned by supervisor.
Requirements
Bachelor's degree in a scientific field or applicable experience.
Minimum of 10 years experience effectively utilizing/implementing a QMS that compiles to CFR820 and ISO13485.
Minimum of 5 years managing and mentoring Quality Engineers and/or Quality Assurance Specialists.
Experience in managing/participating in external audits by regulatory bodies directed against the QMS.
Attention to detail with an ability to technically create and review documentation.
Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
Ability to work independently, and utilize good problem-solving skills.
Ability to multitask and work within a fast-paced dynamic team environment.
Preferred Experience
Prior experience in working in a startup environment.
Prior experience in the molecular diagnostics industry.
Background in molecular biology and/or cancer biology.
Experience with Illumina's NGS instrumentation equipment.
A technical background is highly preferred for this role, with an understanding of molecular biology and genomics.
Compensation
We offer highly competitive salary and benefits combined with a generous equity package. 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.
This hire may be transitioned to higher positions within Quality as experience and skills prove appropriate.
We are seeking an experienced and driven Molecular Biologist tobe a key player in the development of Foresight’s cancer diagnostic workflow. The successful candidate will work within our R&D team to develop and validate cutting-edge cancer diagnostic NGS assays. The successful candidate will work cross-functionally with members of the laboratory operations team, the bioinformatics team, and with other key internal and external stakeholders. This position requires being hands on in the lab, attention to detail, and the ability to design, implement, and validate novel assays for cancer screening and surveillance applications. The successful candidate will have a deep technical understanding of NGS assays and data analysis, strong written and verbal communication skills, the ability to be flexible with tasks, and the ability to work well both independently and in a team environment.
Responsibilities
Act as a core technical lead on the design and execution of R&D efforts leading to new product introductions and
regulatory submissions.
Drive development efforts to optimize assay performance and improve laboratory processes.
Perform complex analysis of large genomic data sets in collaboration with the bioinformatics team.
Be responsible for documentation in compliance with Good Laboratory Practices and Quality Systems Requirements.
Present project updates, data analysis, and experimental conclusions at technical meetings.
Participate in brainstorming sessions and collaborative efforts within a highly interactive work environment.
Mentor junior team members.
Communicate effectively with coworkers and non-laboratory personnel.
Perform other laboratory duties as needed.
Requirements
Ph.D in Molecular Biology, Biochemistry, or related field.
Deep technical understanding of NGS assay development and NGS data analysis.
Ability to design and interpret results of technical experiments aimed at improving assay performance.
Experience with NGS library preparation, hybrid capture-based target enrichment, and Illumina sequencing
workflows.
Ability to troubleshoot and problem solve complex molecular biology workflows.
Strong organizational skills and meticulous attention to detail.
Ability to work proactively and with high integrity as part of a team within a highly collaborative environment.
Dedicated to making a difference in a fast-paced startup environment.
Preferred Experience
Prior Industry Experience.
A strong background in Cancer Biology.
Experience processing patient specimens.
Proficiency with Python, R, Bash scripting or similar programming languages.
Experience with standard NGS bioinformatics tools (e.g. Samtools, Bedtools, BWA, etc.).
We offer highly competitive salary and benefits combined with a generous equity package. 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.
We are seeking an experienced and driven Clinical Laboratory Associate who will be responsible for assisting supporting the daily operations of the Foresight Clinical Laboratory. The work requires excellent attention to detail, effective written and verbal communication skills, the ability to be flexible with tasks and schedules, and the ability to work well both independently and in a team environment. The successful candidate will be a key part of a cross-functional team responsible for securing and maintaining CLIA certification, CAP accreditation, and state licensure for the Foresight Clinical Laboratory, including compliance with all applicable standards and regulations.
Responsibilities
Assist in establishing Foresight’s Clinical Laboratory.
Perform analytical testing activities including specimen accessioning, testing, quality control, and validation
studies according to the laboratory's standard operating procedures.
Maintain reagents, consumables, stock solutions and inventory supply, including preparation and aliquoting of
reagents according to the laboratory's standard operating procedures.
Document all corrective actions taken when test systems deviate from the laboratory's established performance
specifications.
Report all concerns of test quality and/or safety to the Clinical Laboratory Supervisor.
Assist with organizing and maintaining Clinical Laboratory records.
Collaborate with R&D scientists to design and analyze data from experiments to assess and improve assay
performance.
Participate in brainstorming sessions and collaborative efforts within a highly interactive work environment.
Communicate effectively with coworkers and non-laboratory personnel.
Identify process improvement opportunities and report to laboratory management.
Perform other laboratory duties as needed.
Requirements
BA or BS (or equivalent) in Molecular Biology or Physical/Life Science and 2+ years of full-time laboratory
experience.
Must meet the minimum criteria to meet the standards of high complexity testing as required by CAP/CLIA
(biology/physiology; chemistry and physics undergraduate coursework).
Good understanding of underlying scientific principals and working knowledge of testing procedures.
Experience in molecular biology techniques.
Aseptic laboratory skills and ability to perform precise but complex laboratory procedures.
Strong organizational skills and meticulous attention to detail.
Attention to detail and ability to prioritize work in a highly regulated environment.
Ability to work proactively and with high integrity as part of a team within a highly collaborative environment.
Ability to participate in projects and complete assignments as expected with an emphasis on quality.
Flexibility of work schedule to meet the needs of Foresight’s Clinical Laboratory.
Experience with Microsoft Excel, Word, and PowerPoint.
Excellent written and verbal communication skills with ability to maintain open communication with other internal
employees and managers as needed.
Dedicated to making a difference in a fast-paced startup environment.
Preferred Experience
Experience processing patient specimens.
Background in molecular biology and/or cancer biology.
Molecular diagnostics industry experience, ideally in a CLIA compliant laboratory environment.
Experience with NGS library preparation, hybrid capture-based target enrichment, and Illumina sequencing
workflows.
Experience with programming, bioinformatics, or computer science.
Physical Demands/Working Environment
Hours and days may vary depending on operational needs.
Standing or sitting for extended periods of time may be necessary.
May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing
elements, and high-speed centrifugation.
Repetitive manual pipetting may be necessary.
Some lifting (up to 40 pounds) may be necessary.
Standing; walking; climbing stairs; stooping to remove/replace files; good hand-eye coordination; upper body
twisting while handling supplies and equipment; using keyboard for computer and word processing for extended periods
of time will be required.
Specific vision abilities required for this job include excellent close vision, distance vision, color vision,
peripheral vision, depth perception and ability to adjust the focus of the eyes.
Compensation
We offer highly competitive salary and benefits combined with a generous equity package. 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.
