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- and solutions-oriented, collaborative, and communicative individual who is passionate about translating innovative research into clinically validated diagnostic tests.ng with a complex assay to measure genome-wide analytes from blood and working closely with cross-functional teams, 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.
- • Use GDP/GLP/GCP (GXP) to execute studies and generate data at the bench, including working with human whole blood specimens and contriving representative samples.
- 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.
- Repetitive manual pipetting may be necessary.
- Some lifting (up to 50 pounds) may be necessary.
- Collaborate with team members to design and plan studies, review data, and write reports for assay development, verification, and validation.
- Interpret scientific results and provide recommendations for next steps.
- Identify and implement process improvements.
- Troubleshoot assay workflows and equipment.
- Generate process, quality, and design control documentation.
- Remain competent in current laboratory processes and compliant with regulatory requirements such as continuous education (CE) and HIPAA regulations.
- Keep detailed experimental records and communicate data to team members in a thorough, organized, and honest manner.
- Understand key company milestones, departmental goals, and individual contributions.
- Communicate freely and clearly with 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.
- Additional duties as assigned
- 3+ years of laboratory experience (required)
- 1+ years in an industry setting for molecular diagnostic assay development, verification, and validation (required)
- BA/BS or MA/MS in molecular biology, biochemistry, or related field and/or equivalent combination of education and experience (level may be adjusted based on experience)
- Proficiency in molecular genetic techniques, including nucleic acid extraction, PCR, qPCR, immunoprecipitation, and NGS library preparation (required)
- Proficiency in executing bench work under protocol in accordance with GXP (required)
- Ability to thrive in a fast-paced, dynamic environment and handle multiple high priority projects simultaneously (required)
- Demonstrated oral and written communication skills and ability to work closely with team members (required)
- Familiarity with NGS and bioinformatics (preferred)
- Familiarity with statistical analyses in excel or R (preferred)
- Familiarity with LDT/IVD/CDx guidelines from CAP, CLIA, FDA, CLSI, etc. (preferred)
- Familiarity with principles of quality control and design control (preferred)