Spclst, Operations, Tech Supply
Core
Subject Matter Expert for microbiological/virological methods supporting method verification, suitability, and transfer for commercialized biologicals/vaccines.
Role type
Senior IC microbiological/virological specialist (SME)
Builds
Microbiological/virological methods and studies for biologicals/vaccines commercialization
Domain
Pharmaceutical industry / Biologics manufacturing
Required skills
Microbiological/virological methods expertise, GMP compliance, Method validation, Root cause analysis, Project management, Regulatory guidelines knowledge
Preferred skills
Rapid Microbiology Methods (RMM) expertise, Multidisciplinary team collaboration
Technologies
None explicitly stated
Responsibilities
Support method verification and suitability for commercialized products, Provide training to the network, Ensure proper introduction and qualification of methods during transfer, Troubleshoot microbiological issues, Author regulatory filing documents, Participate in method development and validation of alternative technologies, Support analytical investigations and studies, Participate in global change control and root cause analysis
Seniority
Senior, hands-on IC
