Team Leader in Chemical Analysis

vor 4 Wochen

Sankt Wendel, Saarland, Deutschland Fresenius Medical Care Vollzeit

Your Responsibilities

  • Leadership and professional development of the team in the field of chemical analysis.
  • Independent coordination of projects while adhering to current regulatory requirements in a regulated laboratory in accordance with ISO/IEC 17025 standards.
  • Oversight of analyses using Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), as well as coupled Mass Spectrometry (GC-MS, LC-MS, LC-QTOF), and trace metal analysis (ICP-MS, ICP-OES).
  • Development and validation of new testing methods following ICH Q2(R2), Q14, and other relevant guidelines.
  • Management of deviations and implementation of corrective and preventive actions (CAPA).
  • Responsible procurement and management of testing materials, including qualification.
  • Contribution to the overall laboratory processes within a regulated environment.
  • Ensuring the accuracy and reliability of test results.
  • Documentation and reporting in accordance with quality management systems.
  • Creation and review of Standard Operating Procedures (SOPs) within the area of responsibility.
  • Active participation in training and professional development.

Your Profile

  • PhD or equivalent degree in Chemistry, Analytics, or a related field (Biology, Biotechnology, Pharmacy).
  • Several years of professional experience in an ISO/IEC 17025 accredited laboratory in the pharmaceutical industry or a comparable environment, including qualification and management of testing materials.
  • Extensive experience in trace analysis and the field of Extractables/Leachables using GC, HPLC, Mass Spectrometry, and ICP-MS.
  • Proven laboratory experience in a regulated environment, along with leadership and project management skills.
  • Strong persuasive and assertive abilities, coupled with high self-motivation.
  • Excellent command of both German and English, spoken and written.
  • Experience with Laboratory Information Management Systems (LIMS).

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