Analytical Development Principal Scientist, Microbiology & Viral Safety
Core
Lead the development, qualification, validation, and lifecycle management of microbiological and viral safety assays for cell and gene therapy and biologics programs.
Role type
Principal Scientist, Analytical Development (Microbiology & Viral Safety)
Builds
Microbiological and viral safety testing methods and control strategies
Domain
Biotechnology / Cell and Gene Therapy / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology, Virology, Adventitious agent safety, Regulatory submissions, GMP environments, Assay development, Qualification, Validation, Transfer, Lifecycle management, Wet lab experimentation
Preferred skills
Rapid and alternative microbiological methods, Industry consortia participation, Cross-functional collaboration
Technologies
None explicitly listed
Responsibilities
Lead wet lab development activities including hands-on experimental work, Author and review technical dossiers and validation plans for regulatory submissions, Represent the organization in external scientific forums and industry consortia, Provide technical guidance on risk assessment and testing strategies
Seniority
Principal, strategic leadership & hands-on IC