Foresight Diagnostics Inc.
Scientist II, Regulated Assay Development
Foresight Diagnostics Inc., Boulder, Colorado, United States, 80301
Location: Onsite in Boulder, CO
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 Regulated Assay Development group plays a central role at Foresight, engaging at the interface of science, engineering, and operations, to deliver game-changing MRD detection technologies. We are looking for a highly motivated and detail-oriented Reagent Development Scientist II to develop scalable, robust and regulatory-compliant reagent systems for complex NGS-based clinical assays that contribute towards regulatory filings. In this role, the Scientist II will characterize the reagents’ performance, establish and validate quality control assays, and facilitate the transfer of high-quality reagents into operations/manufacturing processes for complete workflow integration. We are looking for a candidate who is comfortable working under the constraints of IVD design controls and ISO13485 guidelines in a cross-functional environment that includes operations, supply chain, automation engineering, bioinformatics quality, and regulatory teams. Strong candidates will have a technical background in NGS and molecular biology along with previous experience in reagent development and laboratory automation.
What You Will Do
Demonstrate an understanding of the complex assay chemistry and process controls and contribute to the development of high-quality reagents and controls
Drive risk-based analytical approaches and lead the development and validation of new QC methods for monitoring the performance and release testing of medium and high complexity reagents
Manage various analytical aspects of the reagent life cycle such as characterization, optimization, and scale up of reagent formulations, establishing tolerance limits, stability, and shelf life for incoming and/or in-house manufactured reagents on automated systems
Execute test methods and other complex NGS workflows using robotic equipment such as liquid handlers
Analyze the complex NGS datasets with appropriate statistical tools independently and collaboratively with biostatisticians
Work with bioinformaticians, assay development scientists, quality, regulatory, and external vendors to develop specifications and robust experimental designs that ensure commercial readiness and troubleshooting plans for deviations and change management within the regulatory constraints
Collaborate with other scientists, automation engineers, bioinformaticians, and operators for developing analysis pipelines and LIMS
Review and identify gaps in new methods to facilitate process improvements and monitor the quality of reagents
Has a quality-driven mindset and strives to enhance the quality of the products/processes in-compliance with the company’s quality management system policies and procedures
Maintain thorough and accurate documentation and develop new plans, SOPs and reports and/or training operators on new methods in accordance with QMS
Contribute to risk assessment and reagent management while regularly coordinating with Operations and other teams as required
Apply critical thinking skills for interpreting results and proactively communicate the findings and next steps with the appropriate stakeholders to help escalate/support the execution of project deliverables under tight deadlines
What You Will Bring Required Qualifications
M.S., or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related field.
With Ph.D., 3+ years of industry experience in NGS assay development.
With M.S., 7+ years of industry experience in NGS assay development.
Strong technical background and hands-on experience in molecular biology techniques, such as DNA/RNA purification and quantification, PCR/qPCR, molecular cloning, enzymatic assays, protein engineering, and Next Generation Sequencing (NGS).
Prior experience in developing and optimizing reagents (enzymes, buffers, oligonucleotides, etc.) for use in molecular assays preferably for NGS workflows using liquid handlers in biotech manufacturing or technical transfer, within FDA regulated and/or ISO13485 environments.
Expertise in handling multiple projects in parallel.
Ability to work as part of a collaborative team and build strong working relationships with multiple and diverse teams.
Self-motivated, willing to learn and be up to date on current scientific literature or new research developments.
Good work ethic with a “can-do” mentality and attitude for approaching challenging questions.
Proficiency in R, Python, bash, or similar.
Eagerness to regularly perform benchwork.
Ability to troubleshoot complex technical issues.
High emotional intelligence and self-awareness.
High attention to detail, time management, and risk.
Evidence-driven, confident, and decisive cross-functional communication.
Ability to adapt in a fast-paced environment.
Preferred Qualifications
Experience in liquid biopsies.
Experience in IVD product development with familiarity in FDA 21 CFR Parts 820 and ISO 13485:2016 or CLIA/CAP regulations.
Experience in developing bioinformatics models.
Experience in mentorship.
Physical and Mental Requirements, Working Conditions
Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.
This position requires the individual to wear and work in personal protective equipment. This individual may be working with potential biohazards related to blood-borne pathogens exposure and may be exposed to human diseases.
Required to stand, walk, and sit; talk or hear, both in person and by telephone or videoconference; use hands to finger, handle, or feel objects or controls; reach with hands and arms. Regularly required to stoop, kneel, bend, crouch and move up to 25/50 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
This is an essential position supporting clinical laboratory operations requiring attendance on weekends, holidays, and during emergency conditions, such as inclement weather and power failure.
This position requires the ability to identify and resolve quality issues.
This position is a full-time, in-person position in Boulder, CO.
Compensation and Benefits This role is hiring at an annual salary of $125,000 – $140,000 and is eligible for bonus and 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.
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.
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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 Regulated Assay Development group plays a central role at Foresight, engaging at the interface of science, engineering, and operations, to deliver game-changing MRD detection technologies. We are looking for a highly motivated and detail-oriented Reagent Development Scientist II to develop scalable, robust and regulatory-compliant reagent systems for complex NGS-based clinical assays that contribute towards regulatory filings. In this role, the Scientist II will characterize the reagents’ performance, establish and validate quality control assays, and facilitate the transfer of high-quality reagents into operations/manufacturing processes for complete workflow integration. We are looking for a candidate who is comfortable working under the constraints of IVD design controls and ISO13485 guidelines in a cross-functional environment that includes operations, supply chain, automation engineering, bioinformatics quality, and regulatory teams. Strong candidates will have a technical background in NGS and molecular biology along with previous experience in reagent development and laboratory automation.
What You Will Do
Demonstrate an understanding of the complex assay chemistry and process controls and contribute to the development of high-quality reagents and controls
Drive risk-based analytical approaches and lead the development and validation of new QC methods for monitoring the performance and release testing of medium and high complexity reagents
Manage various analytical aspects of the reagent life cycle such as characterization, optimization, and scale up of reagent formulations, establishing tolerance limits, stability, and shelf life for incoming and/or in-house manufactured reagents on automated systems
Execute test methods and other complex NGS workflows using robotic equipment such as liquid handlers
Analyze the complex NGS datasets with appropriate statistical tools independently and collaboratively with biostatisticians
Work with bioinformaticians, assay development scientists, quality, regulatory, and external vendors to develop specifications and robust experimental designs that ensure commercial readiness and troubleshooting plans for deviations and change management within the regulatory constraints
Collaborate with other scientists, automation engineers, bioinformaticians, and operators for developing analysis pipelines and LIMS
Review and identify gaps in new methods to facilitate process improvements and monitor the quality of reagents
Has a quality-driven mindset and strives to enhance the quality of the products/processes in-compliance with the company’s quality management system policies and procedures
Maintain thorough and accurate documentation and develop new plans, SOPs and reports and/or training operators on new methods in accordance with QMS
Contribute to risk assessment and reagent management while regularly coordinating with Operations and other teams as required
Apply critical thinking skills for interpreting results and proactively communicate the findings and next steps with the appropriate stakeholders to help escalate/support the execution of project deliverables under tight deadlines
What You Will Bring Required Qualifications
M.S., or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related field.
With Ph.D., 3+ years of industry experience in NGS assay development.
With M.S., 7+ years of industry experience in NGS assay development.
Strong technical background and hands-on experience in molecular biology techniques, such as DNA/RNA purification and quantification, PCR/qPCR, molecular cloning, enzymatic assays, protein engineering, and Next Generation Sequencing (NGS).
Prior experience in developing and optimizing reagents (enzymes, buffers, oligonucleotides, etc.) for use in molecular assays preferably for NGS workflows using liquid handlers in biotech manufacturing or technical transfer, within FDA regulated and/or ISO13485 environments.
Expertise in handling multiple projects in parallel.
Ability to work as part of a collaborative team and build strong working relationships with multiple and diverse teams.
Self-motivated, willing to learn and be up to date on current scientific literature or new research developments.
Good work ethic with a “can-do” mentality and attitude for approaching challenging questions.
Proficiency in R, Python, bash, or similar.
Eagerness to regularly perform benchwork.
Ability to troubleshoot complex technical issues.
High emotional intelligence and self-awareness.
High attention to detail, time management, and risk.
Evidence-driven, confident, and decisive cross-functional communication.
Ability to adapt in a fast-paced environment.
Preferred Qualifications
Experience in liquid biopsies.
Experience in IVD product development with familiarity in FDA 21 CFR Parts 820 and ISO 13485:2016 or CLIA/CAP regulations.
Experience in developing bioinformatics models.
Experience in mentorship.
Physical and Mental Requirements, Working Conditions
Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.
This position requires the individual to wear and work in personal protective equipment. This individual may be working with potential biohazards related to blood-borne pathogens exposure and may be exposed to human diseases.
Required to stand, walk, and sit; talk or hear, both in person and by telephone or videoconference; use hands to finger, handle, or feel objects or controls; reach with hands and arms. Regularly required to stoop, kneel, bend, crouch and move up to 25/50 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
This is an essential position supporting clinical laboratory operations requiring attendance on weekends, holidays, and during emergency conditions, such as inclement weather and power failure.
This position requires the ability to identify and resolve quality issues.
This position is a full-time, in-person position in Boulder, CO.
Compensation and Benefits This role is hiring at an annual salary of $125,000 – $140,000 and is eligible for bonus and 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.
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.
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