The Director of Assay Development will be responsible for supporting and building a team to develop Adela’s cutting-edge technology into commercial ready products. 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.
- Manage a team to support the development of products using Adela’s proprietary genome-wide methylation analysis platform.
- Lead assay feasibility, design & development, verification & validation, and transfer to laboratory operations using Good Laboratory Practice (GLP) and aligned with CAP/CLIA requirements.
- In collaboration with biostats/bioinformatics team and with alignment to CLSI guidelines and regulatory agencies, ensure appropriateness of sample sizes and acceptance criteria for analytical validation studies.
- Ensure appropriate analysis and result interpretation for internal reports and as needed, for external publications (may include scientific meetings and support of manuscript development).
- Troubleshoot assay workflows and optimize workflow components.
- Responsible for managing large projects and/or multiple concurrent projects.
- Contribute to budget planning and manage financial health of assay development projects.
- Provide leadership to assay development staff.
- Clearly and positively translate corporate objectives into departmental goals and team members’ individual contributions to assure team is informed, aligned and engaged.
- Communicate freely and clearly 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.
- Keep up to date with the latest research related to clinical diagnostics, as appropriate.
- PhD in Molecular Biology, Biochemistry, or related field. Relevant experience in biotech can make up for lack of an advanced degree.
- 7 years post graduate or equivalent experience.
- of NGS chemistry and workflows.
- Experienced managing laboratory staff in regulated clinical laboratory setting.
- Clear oral and written communications skills. Ability to work cross-functionally and tailor communication to audiences with varied levels of technical knowledge.
- Familiarity with liquid handling instruments for use in high-throughput laboratories.