Lead Microbiology & Viral Safety Analytical Scientist

Vertex Inc.; Boston (MA); On-site; USD 141,000 - 211,000; Full time

Job summary

Vertex Inc. seeks a Principal Scientist, Analytical Development – Microbiology & Viral Safety to provide strategic leadership for microbiology and virology testing across development programs.

The role focuses on assay evaluation, development, qualification, validation, transfer, and lifecycle management, with emphasis on regulatory submissions and cross-functional collaboration. The ideal candidate will lead rapid method development, collaborate with internal teams and external labs, and guide

Qualifications

• PhD preferred; MS considered with significant relevant experience.
• Extensive experience in assay development, qualification, validation, transfer, and lifecycle management.
• Experience supporting regulatory submissions and health authority interactions.

Responsibilities

• Serve as the primary SME for microbiology and viral safety assays across programs.
• Lead development, qualification, validation, transfer, and lifecycle management of microbiological assays and viral safety assays.
• Provide technical guidance on risk assessment, assay selection, and testing strategies for product development and regulatory milestones.
• Author and review technical dossiers, validation plans, protocols, and reports for regulatory submissions.
• Drive innovation in rapid and alternative microbiological methods to improve testing efficiency.
• Lead wet lab development activities and collaborate with internal and external labs.

Skills

Microbiology

Virology

Regulatory submissions

Cross-functional collaboration

Scientific communication

Adventitious agent safety

On-site leadership

Education

PhD in Microbiology/Virology/Biological Sciences

MS with significant relevant experience

Bachelor's with extensive experience

Job description

Vertex Inc. seeks a Principal Scientist, Analytical Development – Microbiology & Viral Safety to provide strategic leadership for microbiology and virology testing across development programs.

The role focuses on assay evaluation, development, qualification, validation, transfer, and lifecycle management, with emphasis on regulatory submissions and cross-functional collaboration. The ideal candidate will lead rapid method development, collaborate with internal teams and external labs, and guide