Mgr, Lab Operations
PharmaCRO
Job description
Job as Lab Manager (m/f/d) in the Lab Operations department with focus on virology: Lead a laboratory team consisting of approximately 5 - 10 technical staff (biology lab technician/MTLA/BTA or equivalent) within a GCLP environment. Evaluate the immunogenicity of vaccines using serological testing of human biological samples from clinical trials. Lifecycle management of serological assays: development, optimization, qualification, validation and decommissioning of antigen-specific serological assays. Monitoring of analytical methods in routine use and timely control of laboratory results. Responsibility for maintaining the qualification status of the laboratory, including equipment qualification, change management and deviation reporting. Required knowledge, prerequisities and quality: Biological studies (PhD) with a focus on virology. At least 5 years of professional experience (ideally in a matrix structure. Experience in dealing BSL2 pathogens. Familiarity with working in a GMP/GCP environment. Good EDP knowledge. Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://q2labsolutions.com/careers
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