Adela is focused on the detection of cancer and other high-morbidity, high-mortality conditions through a blood test. The Company’s genome-wide methylation analysis technology has the unique ability to distinguish the most highly informative (methylated) regions of the genome from the non-informative regions and preferentially target those informative regions for sequencing. The technology is initially being developed for use across the cancer continuum for detection, diagnosis, and management, and in the future, it will be applied to other conditions beyond cancer. Based in the New Haven, CT, Adela laboratory, you will be a key member of the product development team implementing cutting-edge technology positioned to change the diagnostics testing market. We are seeking a disciplined, detail-oriented individual who is passionate about translating innovative research into clinically validated diagnostic tests. Starting with a complex assay to measure genome-wide analytes from blood, you will contribute to developing, optimizing, and validating the assay with the goal of transitioning it to a diagnostic test in a regulated and high-throughput lab environment.
Responsibilities
* Works cross-functionally to establish an end-to-end assay workflow that meets the needs of product concepts and pharma collaborations.
* Orchestrates the evaluation, planning, and execution of technical feasibility experiments to support improvements to the laboratory process.
* Executes, both directly at the bench and through closely supervised junior staff, product development studies, including contriving samples and testing new methods.
* Provides technical guidance and mentorship to junior laboratory staff regarding laboratory technique, assay troubleshooting, and experimental design.
* Authors technical product development documentation including SOPs, feasibility study reports, and verification and validation protocols and reports.
* Analyzes and interprets results in collaboration with biostatistics and bioinformatics teams.
* Summarizes methods and results for internal reports and, as needed, for external audiences (may include scientific meetings, manuscript development and regulatory submissions).
* Troubleshoots assay workflows, optimizes workflow components, and updates documentation to support workflow improvements.
* Scopes new methods or technologies, evaluates the benefits and impact on current lab processes, performance, throughput, and cost.
* Provide recommendations, and together with teammates and leadership, makes informed decisions on next steps to move projects forward.
* Keep detailed experimental records and communicates data to team members in a thorough, organized, and honest manner.
* Understands key company milestones, departmental goals, and individual contributions; communicates freely and clearly to leadership about any issues and/or barriers that could delay or derail projects.
* Maintains a positive culture by championing inclusion, respect, and empathy toward all Adela teammates, as well as our collaborators, customers, and community. Working Environment/Physical Demands.
* Standing or sitting for long periods may be necessary.
* Safe handling of hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and operation of high-speed centrifuges.
* Travel up to 20% to other Adela Laboratory sites in United States and Canada.
* Repetitive manual pipetting may be necessary.
* Some lifting (up to 50 pounds) may be necessary.
Education and Requirements
* Masters or PhD degree in Molecular Biology, Genetics, Chemistry or related scientific field with more than 10 years relevant laboratory experience.
* Three years of relevant experience with a proven track record in assay development, verification and validation of diagnostic tests (level may be adjusted based on experience).
* Demonstrated ability to work within CAP/CLIA Laboratory Developed Test (LDT) environment.
* FDA IVD design and development experience preferred.
* Knowledge of quality control and quality assurance principles.
* Proficiency in molecular biology techniques including Immunoprecipitation (IP), PCR, and NGS with hands-on experience in NGS based assay development including sample preparation, library preparation, sequencing, and data analysis.
* Ability to execute bench work in accordance with good laboratory practices.
* Thrives in a fast-paced, dynamic environment; can handle multiple high priority projects simultaneously.
* Clear oral and written communications skills and ability to work with team members in the same and adjacent disciplines.