Analytical Science and Technology Principal Scientist
Core
Lead microbiology method lifecycle management, microbial control strategies, and technical oversight for biologics, cell therapy, and gene therapy products in late-stage development and commercialization.
Role type
Principal Scientist (Microbiology)
Builds
Robust, inspection-ready microbiological testing and control strategies for global biologics and cell/gene therapy programs.
Domain
Biopharmaceuticals / Microbiology / Biologics & Cell & Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology method development and validation, Sterility testing, Bioburden testing, Endotoxin testing, Microbial identification, Rapid microbiological methods, GxP compliance, Investigation leadership, CAPA management, Contract laboratory oversight, Regulatory submission support
Preferred skills
Biologics lifecycle management, Cell and gene therapy experience, Commercial manufacturing support, Health authority interaction
Technologies
None explicitly listed
Responsibilities
Lead microbiology method qualification, validation, transfer, and lifecycle management; Develop risk-based microbial control strategies; Lead complex investigations and root cause analyses; Oversee testing at contract laboratories and CMOs; Support regulatory submissions and inspection readiness; Provide technical leadership and mentoring to scientists
Seniority
Principal, hands-on IC with strategic oversight