Associate Director/Director, Assay Product Development

Countable Labs•Palo Alto, CA

About The Position

At Countable Labs, we’re reimagining the future of genomics—and we’d love for you to be a part of it! As the innovators behind our groundbreaking Countable PCR platform, we’re building tools that make a real impact in precision medicine. We’re a fast-growing startup fueled by innovation, collaboration, and a mission-driven spirit. If you’re ready to roll up your sleeves, build something from the ground up, and help shape the future of genomics, we want you on our team! Role Overview The Associate Director/Director of Assay Product Development is a high-visibility leadership position responsible for the end-to-end lifecycle of our Countable PCR assay portfolio. This role oversees the entire continuum of assay product creation—from early-stage conceptualization and wet-bench feasibility to formal product development including verification and validation and manufacturing transfer. The successful candidate will serve as the technical and operational hub of our assay R&D efforts, ensuring that all assay products are developed with the clinical rigor and efficiency required for the molecular diagnostics market. This role offers significant upward potential for a leader who excels in a disciplined, product development process (PDP)-driven environment

Requirements

Education: PhD in Molecular Biology, Bioengineering, Genomics, or a related field.
Industry Experience: 10+ years of experience in the life science industry, with a proven track record of successfully launching PCR and/or NGS-based assay products in a commercial environment, with particular focus in the molecular diagnostics space. Experience as a technical lead in product development core teams. Exact level to be determined based on experience.
Technical Expertise: Deep technical knowledge of multiplexed qPCR, dPCR, and/or targeted NGS panels, including primer/probe design, library preparation, and assay optimization.
Regulatory Knowledge: Extensive experience working within ISO 13485 and Design Control frameworks. Direct experience with IVD (In Vitro Diagnostics) development and regulatory filings is highly preferred.
Operational Skills: Experience managing product development cycles and manufacturing transfer.
Analytical Proficiency: Strong data analysis skills (Python, R, or similar) with the ability to translate complex data into actionable product decisions.
Leadership: Demonstrated ability to lead interdisciplinary teams and manage complex projects in a fast-paced, deadline-driven environment.
Communication: Excellent verbal and writing skills, and exceptional attention to detail. Demonstrated ability to present externally through webinars and customer presentations.
Ability to thrive in a fast-paced, dynamic startup environment: Ability to balance scientific rigor and processes with adaptability as priorities evolve

Responsibilities

End-to-End Product Ownership: Direct the development of new assay products to be built on Countable PCR through the entire lifecycle: initial feasibility and assay optimization, design and development of reports specific to the application of the assays, approval of product requirements and defining specifications, verification and validation (V&V), commercial release, and post-launch sustaining and troubleshooting.
NPI and Manufacturing Transfer: Work with NPI and supply chain functions to ensure smooth transition of assay products into production.
PDP Leadership: Drive the Assay team’s adherence to the Product Development Process (PDP). Ensure all technical files and Design Controls comply with ISO 13485 and relevant regulatory standards.
Active Leadership (Player-Coach): Maintain a hands-on presence in the laboratory and data analysis (if needed), provide technical guidance on assay design and optimization, review critical experimental design for V&V, troubleshoot complex multiplex chemistries, and ensure the team meets aggressive development milestones.
Cross-Functional Integration: Act as the primary technical liaison between other R&D functions, Quality, Product, and Operations to ensure a unified approach to product performance and user experience.
Operational Excellence: Implement disciplined workflows for experimental documentation and data analysis to improve development velocity.
Team Development: Build and mentor a high-performing team of scientists and analysts, fostering a culture of accountability, technical excellence, and proactive communication.

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