Distinguished Scientist, Microbiology
Core
Define strategic and technical capability for microbiology to support small molecule, biologics, and vaccine candidates in clinical development.
Role type
Distinguished Scientist (Individual Contributor, Enterprise Leadership)
Builds
Microbiology Network capabilities for R&D and commercialization
Domain
Pharmaceutical R&D, Microbiology, Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiological Analysis, GMP Compliance, Analytical Chemistry, Molecular Microbiology, Project Leadership, Regulatory Compliance, Cell-Based Assays, Clinical Development, Technical Reporting, Scientific Leadership
Preferred skills
Next Generation Sequencing (NGS) strategy, Rapid Microbiological Methods (RMM), Advanced Microbiology Methodologies
Technologies
NGS, RMM, GMP documentation systems, Analytical methods
Responsibilities
Provide strategic/technical oversight of raw material testing and in-process control (IPC) analysis; oversee GMP release and stability activities; manage area status and GMP readiness including equipment and documentation; author and approve GMP documentation and SOPs; oversee change management, investigations, and corrective action plans; participate in audits and inspections; drive implementation of new analytical technologies.
Seniority
Distinguished, Enterprise-level IC with strategic oversight