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Senior Laboratory Vendor Manager

vor 2 Monaten


Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit
Job Description

The Senior Laboratory Vendor Manager is responsible for the selection, oversight, and management of our central and specialty laboratory vendors. This role is essential to achieving the bioanalytical objectives as part of our clinical development programs.

Key Responsibilities:
  • Vendor Management: Identify, select, and oversee central and special laboratories for our clinical trials in terms of quality, costs, and capabilities.
  • Deliverable Oversight: Ensure that vendors meet or exceed expected timelines for test results, adhere to industry standards and regulations, and escalate, support the solution of, and communicate issues to all relevant stakeholders.
  • Assay Development and Transfer, Laboratory Readiness: Work closely with other Miltenyi teams to ensure that transferred assays and reference ranges are validated, verified, and harmonized at our lab vendors. Ensure that labs are operationally ready as planned.
  • Stakeholder Management: As First Point of Contact (FPOC) between Miltenyi and the laboratories, keep the internal trial teams and other stakeholders updated about the suppliers' performance. Participate in appropriate meetings.
  • Quality Metrics and Continuous Improvement: Frequently evaluate, track, and report our lab supplier performance, cost efficiency, and compliance, and identify and implement new strategies for process improvement and cost reduction.
Requirements:
  • A Master's degree or higher, ideally a PhD in biochemistry, biology, pharmacy, or a related field, along with several years of experience in a clinical laboratory, biotech, pharma, or CRO setting.
  • A thorough understanding of the legal framework pertinent to the development of bioanalytical assays and the quality standards for laboratory data in clinical research (EU, USA) is crucial for this role. Experience in managing vendors, projects, and laboratory processes is preferred.
  • Robust communication and negotiation skills, the ability to work under pressure, and dependability.
  • Fluency in German (C1) and business-proficient in English (B2).
  • A high level of accountability, extroversion, a team and action-oriented approach, problem-solving abilities, and skills in setting priorities.