Director of Assay Development

4 days ago


San Jose, California, United States Visby Medical Full time
Job Title: Director of Assay Development

About the Role:

We are seeking a highly experienced Director of Assay Development to lead our assay development team at Visby Medical. As a key member of our R&D team, you will be responsible for designing, validating, and optimizing PCR-based assays to ensure they meet the highest standards of performance and regulatory compliance.

Key Responsibilities:

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

Requirements:

* 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.

What We Offer:

* Competitive salary range: $180,000 - $240,000 (based on location).
* Highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option.
* 401k match, flexible paid time off, 11 company holidays, and many other contemporary benefits and perks.

About Visby Medical:

We are a proud recipient of the 2023 Cigna Healthy Workforce Designation. We believe that the unique contributions of all Visbees is the driver of our success. We are committed to creating a workplace that is inclusive, diverse, and equitable.

Equal Employment Opportunity:

Visby Medical is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is free from discrimination and harassment.

Full COVID Vaccination Required:

Reasonable accommodations for medical or religious reasons considered.

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