Director of Assay Development
115 Munson St
New Haven, CT 06511
Adela is seeking a highly motivated and creative Director of Assay Development for a full-time position to join our New Haven, CT Laboratory team. This is an exciting opportunity to be part of a growing, dynamic, and collaborative company focused on delivering cutting-edge technology. The Director of Assay Development will provide leadership and technical competence for developing, validating, and implementing clinical-grade molecular assays utilizing Adela’s unique and powerful DNA methylation-based technology.
- Leads the scientific team responsible for the progression of proof-of-principle assays through development, optimization, validation, and transfer to laboratory operations for implementation in production.
- Works closely with CSO and business development leadership to identify and prioritize assays for entry into the product development process.
- Leads multiple concurrent projects both independently and collaboratively.
- Plans and executes experimental work required for assay development and validation studies.
- Recruits, leads, and develops a highly effective team of development scientists responsible for transitioning conceptual assays to clinical products.
- Defines assay development plans for each stage of the product development process.
- Responsible for biomarker development in addition to methylated DNA.
- Present technical data, including issues, risks, and opportunities to cross-functional audiences.
- Authors required design control documentation following Adela’s quality management system.
- Recommends innovative approaches to develop and implement new, robust assay platforms.
- Builds a positive work environment based on accountability, collaboration, and effective communication.
- Completes performance assessments of direct reports.
- Experience performing development activities under design control and working within a regulated environment (FDA, CAP, CLIA)
- Extensive experience with molecular biology techniques and an understanding of the practices and principles of NGS, including library preparation, nucleic acid extraction (especially cell-free DNA), and amplification techniques
- Hands-on experience with the use of automated instrumentation is a strong plus; e.g., liquid handlers, nucleic acid isolation and purification.
- Proven success in assay development, including experience with high-throughput experiment design and analyses.
- Demonstrated success in transitioning molecular assays from development to released product.
- Expertise with nucleic acid sequencing data analysis and interpretation methodologies
- Adept at writing clear, detailed plans, reports, and SOPs
- Conduct and oversee multiple projects independently and provide rigorous analysis of the results.
- Manage and train laboratory staff in the execution and troubleshooting of molecular assays.
- Passionate and engaged, demonstrated success in identifying effective and efficient solutions to complex problems.
- Effective written and verbal communicator who interacts seamlessly across diverse teams in the organization.
Education and Experience
Master’s, or Doctoral degree in a relevant field with at least 8 years’ or 6 years’ experience, respectively, in molecular diagnostic and sequencing assay development; commercial setting preferred.
How to Apply
Interested applicants please apply to: [email protected]