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Summary 

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.  

Responsibilities: 

• 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 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.    
• Keep up to date with the latest research related to clinical diagnostics, as appropriate.  

Key Requirements: 

• 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. 
• Knowledgeable 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.