Mgr, Lab Operations

IQVIA • Data & Analytics • Health Care • Doctoral Degree (PhD) • 3 years ago
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Salary
≈ $67k – $154k per year (Estimated)
Location
In office (Marburg)
Seniority
Senior · 5+ years exp
Employment
Full-Time
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IQVIA

IQVIA is an American company formed in 2016 by the merger of the contract research organisation Quintiles, founded in 1982, with the pharmaceutical data business IMS Health. It runs clinical trials on behalf of drug and device makers and simultaneously operates one of the largest healthcare data estates in the world, covering prescriptions, claims and electronic medical records, which it sells back to the same industry for commercial planning and real-world evidence studies. Headquartered in Durham, North Carolina and listed on the New York Stock Exchange, it employs close to ninety thousand people and combines the trial and data businesses in what it calls connected intelligence.
iqvia.com • HQ: Durham, United States • Data Quality • Data & Analytics • Health Care • Clinical Research • 5000+ employees • Est. 1982

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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