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Countable Labs · 3 weeks ago

Associate Director/Director, Assay Product Development

Palo Alto, CA

Full-time

Onsite

Lead/Staff, Director/Executive

10+ years exp

Countable Labs is a fast-growing startup focused on reimagining the future of genomics through innovative tools like the Countable PCR platform. The Associate Director/Director of Assay Product Development will oversee the entire lifecycle of assay products, ensuring clinical rigor and operational excellence in the molecular diagnostics market.

BiopharmaBiotechnologyClinical TrialsLife Science

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

Qualification

Molecular BiologyPCR product developmentMultiplexed qPCRISO 13485 knowledgeNGS panelsData analysis PythonData analysis RLeadershipTeam developmentCommunication skills

Required

PhD in Molecular Biology, Bioengineering, Genomics, or a related field

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

Deep technical knowledge of multiplexed qPCR, dPCR, and/or targeted NGS panels, including primer/probe design, library preparation, and assay optimization

Extensive experience working within ISO 13485 and Design Control frameworks

Experience managing product development cycles and manufacturing transfer

Strong data analysis skills (Python, R, or similar) with the ability to translate complex data into actionable product decisions

Demonstrated ability to lead interdisciplinary teams and manage complex projects in a fast-paced, deadline-driven environment

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