Associate Director, Diagnostic Assay Development (San Diego Metropolitan Area, CA)

Company: Cedent
Location: San Diego
Posted on: March 2, 2025

Job Description:

Role DescriptionThis is a full-time on-site role for an Associate Director, Diagnostic Assay Development at Client in the San Diego Metropolitan Area. The Associate Director, Diagnostic Assay Development will be responsible for defining and leading all aspects of diagnostic assay development from initial introduction (i.e., transfer from R&D or other source) through optimization, validation, and transfer to production. Reporting to the VP, Clinical Operations, this role will enable the launch of new clinical diagnostic assays for neurodegenerative disorders. This is an on-site role, and experience with CAP/CLIA is required. The ideal candidate will have experience with Design Control, patient testing, writing, and validation protocols.Responsibilities

• Plans, designs, and executes analytical experiments and develops methods through all stages/phases of design, development, and the assay life cycle
• Prepares and reviews documents associated with all phases of Design Control
• Provides expertise in stability studies
• Supports the clinical diagnostic laboratory in the design and implementation of appropriate assay controls
• Ensures transfer to laboratory operations using good laboratory practice and alignment with CAP/CLIA
• Troubleshoots and optimizes assay components and workflows
• Contributes expertise to instrumentation, data interpretation, and reporting
• Represents the development team in all meetings on product development and provides guidance to ensure success of product launch
• Creates and contributes to the preparation and review of SOPs, forms, or other laboratory documentation requirements
• Interacts with laboratory and executive management in communicating project status and resourcing
• Provides oversight and direction to direct reports, as applicable
• Performs other duties as requiredRequirements
• PhD with a minimum of 8-10 years of experience in molecular biology, biochemistry, chemistry, or related field
• Minimum of 5 years in a leadership/management role
• Extensive experience in diagnostic assay development of chemistry or molecular-based platforms in a variety of matrices (i.e., CSF, skin, blood)
• Experience with seed amplification assays preferred
• Strong knowledge of US and EU diagnostic regulations
• Demonstrated technical expertise and innovation via publications and product launch
• Strong analytical and critical thinking skills
• Strong leadership capabilities and the ability to lead multiple concurrent projects
• Excellent written, oral, and collaboration skills
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Keywords: Cedent, San Diego , Associate Director, Diagnostic Assay Development (San Diego Metropolitan Area, CA), Executive , San Diego, California