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Scientist I/II, Regulated Assay Development

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 Scientist I/II is responsible for designing, planning, executing, and analyzing studies to characterize, verify, or validate assays developed at Foresight. You will be hands-on in the lab, working with other members of the Foresight Regulated Assay Development team to develop next generation sequencing products for cancer patients. You will play a critical role delivering results in a fast-paced and growing organization.

What You Will Bring

  • B.S., M.S., or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, Chemistry, or a related field.

  • 5+ years of industry/post baccalaureate academic experience.

  • Familiarity with regulatory requirements for assays with different types of risk profiles.

  • Understanding of the steps of the product development process.

  • Mastery of common molecular techniques and NGS library preparation and the ability to troubleshoot complex technical issues.

  • High attention to detail inside and outside of the laboratory.

  • Experience creating figures, data visualizations, written protocols and/or presentations that clearly communicate complex scientific information and concepts for a broad audience.

  • Experience with Python, R, Bash, or similar is desirable

  • Strong organizational and time management skills.

  • Ability to adapt to a fast-paced environment.        

   

What You Will Do    

  • Lead and participate in the design, planning, execution, and reporting of multiple verification and/or validation studies carried out by the regulated assay development team.

  • Provide technical input to support cross-functional deliverables such as trace matrices and failure modes & effects analyses.

  • Collaborate with bioinformatics, quality, regulatory, research, and clinical teams on product development deliverables.

  • Educate junior team members about basic lab techniques, study design and execution, analysis, troubleshooting, and effective scientific communication.

  • Keep meticulous and consistent documentation of all work performed or overseen in compliance with Good Laboratory Practices and Quality Systems.

  • Streamline processes to enhance efficiency and accelerate productivity of the team.

Physical Requirements

  • This position requires the individual to wear and work in personal protective equipment.

  • This position requires that the individual is able to lift a minimum of 25lbs.

  • Substantial movements (motions) of the wrists, hands, and/or fingers are required.

  • Required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures, writing and reviewing documents, and pipetting small volumes of clear liquids.

This role is hiring at an annual salary between $110,000 - $132,000 and is eligible for equity offerings. Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.

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 February 15, 2025.

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.

 

Average salary estimate

$121000 / YEARLY (est.)
min
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$110000K
$132000K

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What You Should Know About Scientist I/II, Regulated Assay Development, Foresight Diagnostics Inc.

If you're looking for an exciting opportunity to make a real difference in the world of cancer detection, Foresight Diagnostics is the place to be! As a Scientist I/II, you'll be on-site in beautiful Boulder, Colorado, diving directly into the cutting-edge realm of regulated assay development. Our dynamic team is focused on transforming molecular diagnostics through non-invasive techniques developed at Stanford University. You'll have the responsibility to design, plan, execute, and analyze various studies essential for characterizing and validating our innovative assays. With a solid background in molecular biology, biochemistry, or a related field, along with a minimum of five years post-baccalaureate experience, you'll thrive in this fast-paced environment where creativity is encouraged. We seek someone who is not only familiar with regulatory requirements and the product development process but also someone who is passionate about collaboration. You'll work hand-in-hand with bioinformatics, quality, regulatory, and clinical teams to deliver impactful results. Additionally, mentoring junior team members and streamlining efficient laboratory processes will be an integral part of your role. If you bring proficiency in NGS library preparation and are adept with data visualization tools, we want you on our team! Plus, with our supportive culture and growth opportunities, there's no limit to what you can achieve at Foresight Diagnostics.

Frequently Asked Questions (FAQs) for Scientist I/II, Regulated Assay Development Role at Foresight Diagnostics Inc.
What responsibilities does a Scientist I/II at Foresight Diagnostics have?

As a Scientist I/II at Foresight Diagnostics, your primary responsibilities include designing, planning, executing, and analyzing studies to characterize and validate assays. You'll lead verification and validation studies while collaborating with bioinformatics and clinical teams to support product development deliverables. Education of junior members in lab techniques and maintaining precise documentation compliant with Good Laboratory Practices are also key duties.

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What qualifications are needed for the Scientist I/II role at Foresight Diagnostics?

Candidates for the Scientist I/II role at Foresight Diagnostics should hold a B.S., M.S., or Ph.D. in fields such as Molecular Biology, Biochemistry, or Chemistry. Additionally, a minimum of 5 years of industry or relevant academic experience is required. Familiarity with regulatory standards and mastery of molecular techniques and NGS library preparation are essential.

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How can a Scientist I/II contribute to team success at Foresight Diagnostics?

A Scientist I/II contributes to team success by leading assay development projects, sharing expertise in regulatory practices, and promoting efficient laboratory processes. Collaboration with cross-functional teams to meet product development milestones and educating junior members also enhance overall team productivity and accuracy.

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Is it necessary to have programming skills for the Scientist I/II position at Foresight Diagnostics?

While it's not mandatory, having experience in programming languages such as Python, R, or Bash is desirable for the Scientist I/II position at Foresight Diagnostics. These skills can enhance data analysis capabilities and facilitate technical problem-solving in assay development.

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What are the career advancement opportunities for a Scientist I/II at Foresight Diagnostics?

Foresight Diagnostics encourages professional development, offering significant opportunities for career advancement for high-performing individuals in the Scientist I/II role. Success in this position can lead to upward mobility within the company as the organization grows.

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Common Interview Questions for Scientist I/II, Regulated Assay Development
Can you describe your experience with regulatory requirements for assay development?

In discussing your experience, emphasize specific assays you've worked on that involved meeting various regulatory standards. Explain how you ensured compliance throughout the development process while maintaining the integrity and accuracy of your work.

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What molecular techniques are you most proficient in?

Highlight the molecular techniques you're experienced with, such as PCR, qPCR, or NGS, and provide examples of projects where you successfully applied these methods. Detail how you troubleshoot technical challenges while adapting to fast-paced environments.

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How do you approach designing a validation study?

When asked about designing a validation study, outline your step-by-step process, such as defining objectives, selecting appropriate controls, and identifying the necessary statistical analyses. Emphasize collaboration with cross-functional teams and meticulous documentation.

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How have you communicated complex scientific information to non-scientific audiences?

Share an instance where you presented scientific data or results to a non-scientific audience. Discuss the strategies you employed to simplify concepts and enhance understanding, such as using visuals or analogies.

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What experience do you have with NGS library preparation?

Discuss specific NGS library preparation techniques you've performed, addressing any challenges faced and how you overcame them. Mention any tools or protocols used that contributed to successful library preparation outcomes.

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How do you handle tight deadlines and multiple projects?

Describe your time management techniques and prioritize tasks when facing tight deadlines. Provide examples of how you maintained productivity without compromising the quality of your work, showcasing your ability to thrive in high-pressure situations.

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What motivates you in your work as a scientist?

Express your passion for research, innovation, and making a tangible impact in cancer diagnostics. Highlight specific areas of assay development that excite you and how they align with Foresight Diagnostics' mission.

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Can you share an example of a successful collaboration you participated in?

Provide details about a collaborative project where you contributed effectively. Discuss your role, the outcome of the project, and how teamwork facilitated successful results, emphasizing the importance of communication and shared goals.

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How do you ensure good laboratory practices in your work?

Highlight specific strategies you employ to maintain good laboratory practices, such as meticulous documentation, adhering to safety protocols, and fostering a culture of compliance among team members. Provide examples of how these practices improved workflow.

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What do you see as the key challenges in developing regulated assays?

Discuss potential challenges such as meeting regulatory compliance, navigating complex validation processes, or technical difficulties in assay performance. Share strategies you've implemented to overcome these challenges and emphasize the importance of adaptable problem-solving.

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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
January 11, 2025

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