Team Leader in Chemical Analytics

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 according to ISO/IEC 17025 standards.
  • Management 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 in accordance with ICH Q2(R2), Q14, and other guidelines.
  • Handling deviations and implementing corrective and preventive actions (CAPA).
  • Responsible procurement and management of testing materials along with qualification.
  • Contributing to the overall laboratory processes in a regulated environment.
  • Ensuring the accuracy and reliability of test results.
  • Documentation and reporting in compliance with quality management systems.
  • Creation and review of Standard Operating Procedures (SOPs) within the area of responsibility.
  • Active participation in training and continuing education.

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 within the pharmaceutical industry or a comparable environment, as well as in the 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.
  • Significant laboratory experience in a regulated environment, along with leadership and project management experience.
  • Strong persuasive and assertive skills, coupled with high self-motivation.
  • Excellent proficiency in both German and English, both written and spoken.
  • Experience with Laboratory Information Management Systems (LIMS).

At Fresenius Medical Care, we are committed to creating a diverse and inclusive workplace that values the unique backgrounds and perspectives of all employees. We offer opportunities for professional growth and development, ensuring our team members can thrive in their careers while contributing to our mission of improving patient care.

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