Director of Assay

About Visby

Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.

About the job

As the Director of Assay, you will lead the assay development team at Visby Medical, overseeing the entire lifecycle of assay development from concept through commercialization. You will be responsible for designing, validating, and optimizing PCR-based assays, ensuring they meet the highest standards of performance and regulatory compliance. This role requires a deep understanding of molecular biology, strategic leadership, and a strong ability to mentor and develop a high-performing team. You will also serve as a key contributor to regulatory submissions, leveraging your excellent scientific writing skills and deep understanding of FDA requirements.

How you'll make an impact

Leadership and Team Management:

• Lead and provide strategic direction to the assay development team, fostering a culture of collaboration, innovation, and continuous improvement.
• Manage internal scientists, external collaborators, and third-party vendors to ensure the successful design, development and optimization of assays.
• Mentor and develop team members, instilling excellence in bench skills, scientific thought, technical writing, and project management.

Strategic Planning:

• Serve as the subject matter expert for assay design and development at Visby, advising senior management on strategic initiatives to enhance assay products and services.
• Collaborate with Product Management and other stakeholders to define assay development goals and roadmaps that align with overall business objectives.

 Assay Design and Development:

• Lead the design and optimization of PCR-based assays, utilizing advanced bioinformatics tools for in silico analysis of sequence alignments and mismatches.
• Ensure all assay development is conducted with rigorous adherence to Design Control practices, following the Visby New Product Development (NPD) process
• Ensure thorough documentation of all development processes, experimental results, and data analyses to support internal decision-making and regulatory submissions.
• Serve as the R&D representative on core teams. Where appropriate, act as the core team leader on product development projects. 

Technical Excellence and Innovation:

• Stay abreast of emerging technologies and industry trends in molecular diagnostics to drive innovation and continuous improvement in assay development.
• Partner with the Design Quality Assurance team to establish and maintain robust quality systems and standard operating procedures to ensure the highest standards of assay performance and reliability.
• Foster partnerships with external collaborators, academic institutions, and industry experts to enhance Visby's assay development capabilities.

Resource Management:

• Manage departmental budgets, resource allocation, and project timelines to ensure efficient and effective execution of assay development programs.
• Recruit, onboard, and retain top-tier scientific talent, building a strong and dynamic team committed to advancing Visby's mission.
• Contribute to writing new grant proposals as well as to technical progress reports for ongoing grants

On your first day we'd like you to have:

• Ph.D. in Molecular Biology, Biochemistry, Microbiology, or a related field, with 10+ years of experience in assay development within the biotechnology or diagnostics industry.
• Proven leadership experience (5+ years) managing and developing high-performing scientific teams.
• Extensive experience in PCR assay design and optimization, including proficiency in bioinformatics tools for in silico analysis and sequence alignment.
• Demonstrated expertise in design control and New Product Development (NPD) processes, specifically for molecular diagnostics in infectious disease applications
• Significant experience participating in multiple FDA submissions, with a deep understanding of regulatory requirements and study requirements.
• Exception