Job Description

Job Title: QC Chemist

Job Description

The QC Chemist serves as a Method Transfer Lead (MTL) and a QC expert within the QCSV group. This role involves a significant understanding of analytical method transfer and/or validation to ensure compliance with cGMP and regulatory expectations. As an individual contributor, you will play a crucial role in supporting the method transfer and validation processes both internally and externally.

Responsibilities

  • Support the Project Lead for method transfer and/or validation for assigned programs.
  • Author or review protocols and reports for method transfer, validation, and bridging, as well as other technical development reports.
  • Plan and track deliverables related to method transfer and validation.
  • Collaborate and interact with internal and external QC testing sites, project leads, and functional representatives.
  • Review method transfer and validation assays, perform data...
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