Mgr, Lab Operations

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 

Healthcare analytics, technology, and clinical research services powering life sciences R&D. Based in Durham, NC.

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