Laboratory Manager Quality Control Physico-Chemical Analytics

Laboratory Manager Quality Control Physico-Chemical Analytics

Lonza

Basel, Switzerland

 

Key Responsibilities

  • Lead a Clinical QC Phys-Chem analytical lab incl. equipment/infrastructure ownership, supporting pharmaceutical development projects through all phases of development up to market authorization readiness.
  • Manage a team of laboratory scientists, providing feedback and tracking performance.
  • Ensure timely delivery of QC work-packages, including documentation and reports.
  • Adhere to Key Quality Indicators (KQIs) and other quality metrics to ensure analytical testing and reporting timelines are met. Support the lab team in assessing test failures and OOX events, collaborating closely with the QC planner to ensure effective scheduling.
  • Act as process owner, improving and maintaining compliant processes, supporting central initiatives, and representing QC in customer audits and regulatory inspections.
  • Address and resolve potential risks/issues, communicating effectively with collaborators.

Key Requirements

  • MSc or equivalent experience in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field (PhD preferred).
  • Solid understanding of phys-chem analytics, protein analytics, and relevant analytical techniques and their application following GMP regulations incl. data integrity. Knowledge in analytics of ADCs and/or mRNA, ideally under GMP regulations, is a plus.
  • Proven experience in people management and performance management.
  • Experience in quality record management, including investigating deviations and leading Change Requests and CAPAs.
  • Ability to appropriately prioritize multiple demands and lead defined work to successful conclusion on time.
  • Excellent communication in English and a problem-solving approach.

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