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.
• Exceptional technical and scientific writing skills, with a track record of producing high-quality internal reports and external communications.
• Strong project management skills, with the ability to lead complex projects from concept to completion while meeting quality, timeline, and budgetary goals. Proactive and clear communicator at first signs of a schedule slip and/or budget/resource issue, with clear root cause, mitigations and recommendations. Excels at driving alignment across functions and at all levels of the organization.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and stakeholders at all levels.
• Experience collaborating with external partners and managing outsourced projects to augment internal capabilities.

It’s great if you have:

• Experience with point-of-care diagnostic platforms and understanding of the unique challenges and opportunities in this space.
• Background in developing multiplexed assays and familiarity with emerging assay technologies.
• Knowledge of international regulatory standards, including ISO 13485 and CLIA regulations.
• Experience working with government funded projects, including ones that require collaboration with external labs
• Experience developing and validating reagent QC methods, with good statistical justification for acceptance criteria

More about the team:

You will be joining a high-performing and collaborative R&D team at Visby, composed of assay scientists, chemists, and mechanical and electrical engineers. Together, we are dedicated to creating groundbreaking PCR diagnostic devices that make a real difference in healthcare. We value innovation, scientific rigor, and teamwork, and we are excited to welcome a dynamic and experienced Director of Assay who shares our passion and commitment to excellence.

Unique aspects of this job:

• Travel: Minimal travel expected (up to 5%) for conferences, collaboration meetings, and regulatory consultations.
• Schedule: Full-time position - onsite 5 days per week.
• Physical Aspects: Primarily office and laboratory-based work involving standing, sitting, and walking; occasional handling of standard laboratory equipment and safe chemical handling procedures.

Salary range: 

• $180,000 - $240,000 (Salary range for candidates based in San Jose, CA)
• Compensation for the role is based on geographical location. 
• Compensation also depends on a number of factors including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown.