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Director of Assay Development

Organization

Adela

Job Location

115 Munson St
New Haven, CT 06511
United States

Job Description

 

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.

Position Responsibilities

  • 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.

Requirements

Required Skills

  • 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]

About Our Organization

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.