Microbiology & Viral Safety Lead — Principal Scientist

Vertex Pharmaceuticals Incorporated; Boston (MA); Vor Ort; USD 150.000 - 202.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Equity awards

Health benefits

Zusammenfassung

Vertex Pharmaceuticals Incorporated is seeking a Principal Scientist, Analytical Development – Microbiology & Viral Safety to provide strategic leadership for microbiology and viral safety testing across development programs.

This role leads assay development, qualification, validation, transfer, and lifecycle management, driving regulatory submissions and cross-functional collaborations to ensure program success and regulatory readiness.

Qualifikationen

• Advanced degree in Microbiology, Virology, Biological Sciences, Pharmaceutical Sciences; PhD preferred (MS considered)
• PhD + 4+ years, or MS + 7+ years, or BS + 10+ years in industry
• Significant experience in assay development, qualification, validation, transfer, and lifecycle management

Aufgaben

• Serve as SME for microbiology and viral safety assays across programs; provide strategic leadership for development, manufacturing, and regulatory objectives
• Lead development, qualification, validation, transfer, and lifecycle management of microbiological assays (mycoplasma, sterility, Gram stain, endotoxin) and viral safety assays
• Provide guidance on microbiological risk assessment, assay selection, and testing strategies to support product development and regulatory milestones
• Author and review dossiers, validation plans, protocols, reports for regulatory submissions and inspections
• Drive innovation in rapid and alternative microbiological methods to improve testing efficiency and scalability
• Lead evaluation and implementation of rapid microbiological methods with internal teams and external labs
• Represent the organization in external forums and consortia to advance best practices
• Lead hands-on wet lab development activities

Kenntnisse

Microbiology

Virology

Adventitious agent safety

Assay development

Regulatory submissions

Cross-functional collaboration

Scientific communication

Ausbildung

PhD preferred; MS considered based on experience

PhD + 4+ years OR MS + 7+ years OR BS + 10+ years

Jobbeschreibung

Vertex Pharmaceuticals Incorporated is seeking a Principal Scientist, Analytical Development – Microbiology & Viral Safety to provide strategic leadership for microbiology and viral safety testing across development programs.

This role leads assay development, qualification, validation, transfer, and lifecycle management, driving regulatory submissions and cross-functional collaborations to ensure program success and regulatory readiness.