QC Microbiology Laboratory Manager

4 weeks ago


King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time
Job Summary

We are seeking a highly skilled QC Microbiology Manager to lead our quality control microbiology laboratory in Upper Merion Biopharma. The successful candidate will be responsible for planning and prioritizing resource allocation to meet testing requirements for product release, raw material, utility, in-process, etc.

Key Responsibilities
  • Oversee the operation of QC Microbiology area, including bioburden, endotoxin, and other microbiology testing areas.
  • Manage training of quality control analysts, transfer assays from the development group, qualify, and validate new assays, and implement assays for quality control purposes.
  • Conduct laboratory investigations related to product testing, compile reports in support of product filings with regulatory agencies, and review and release of test results.
  • Ensure full cGMP compliance in laboratory operations, prepare documents to support regulatory filing, and work directly with other QC groups to ensure timelines are met.
  • Collaborate and work effectively within the Quality Control groups as well as other departments, represent the quality control department, and review and update regulatory documents as required.
Requirements
  • Bachelor's degree in a relevant field.
  • 3+ years' experience in microbiology, 5+ years' experience in supervisory or leadership skills, and 5+ years of GxP regulated environment.
  • 7+ years' experience in biopharma, strong interpersonal and leadership skills, solid team player able to function within a team-based organization, and strong verbal and written communication skills.
About GSK

GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines, focusing on the science of the immune system and the use of new platform and data technologies.



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