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 will be applied to other conditions beyond cancer.
Summary
Residing in the clinical laboratory based in the Bay Area 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 the regulated and high-throughput lab environment.
Responsibilities:
- Author product development documentation including feasibility, verification and validation protocols and reports in collaboration with team members.
- Work cross-departmentally with the Quality and Regulatory team to ensure procedures are performed using calibrated equipment, controlled reagents, and appropriate quality controls and based on internationally recognized standards and regulations.
- Remain competent to current laboratory processes and compliant with regulatory requirements such as continuous education (CE) and HIPAA regulations.
- Execute product development studies at the bench including work with whole blood specimens.
- Analyze results in collaboration with biostats/bioinformatics team.
- Summarize and interpret results for internal reports and as needed, for external publications (may include scientific meetings and support of manuscript development).
- Provide recommendations and together with teammates and leadership, make informed decisions on next steps to move projects forward.
- Troubleshoot assay workflows, optimize workflow components and update documentation to support workflow improvements.
- Keep detailed experimental records and communicate data to team members in a thorough, organized and honest manner.
- Lead from the bench by providing guidance and mentorship to junior laboratory staff regarding best practices for the clinical laboratory as the team grows.
- Understand key company milestones, departmental goals and individual contributions; communicate freely and clearly to leadership about any issues and/or barriers that could delay or derail projects.
- Maintain a positive culture by championing inclusion, respect and empathy toward all Adela teammates, as well as our collaborators, customers and community.
Requirements
- BS/MS in molecular biology, biochemistry or related field
- A minimum of 6 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.
- Experience generating formal protocols and reports under design control.
- 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, and sequencing.
- 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.