QC Specialist

Brightwater

Limerick

One of the most dynamic Biopharma sites in Munster has a vacancy for an ambitious Quality Control Scientist to lead assay development , characterization, optimization, transfer, validation and investigation for QC chemistry group. You will provide technical support, guidance and supervision for release, stability, and in-process testing and assay development. About the Job: Performs assay development/validation for QC Chemistry or Biochemistry groups. Reviews new test procedures and assays. Evaluates and bring in new methodologies/techniques when needed. Facilitate assay transfer from R&D and to business partners. Organize analytical assay transfer internally and externally. Lead technical troubleshooting and problem investigation. Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance. Participates in training programs for analysts. Represent QC in project teams and provide Quality input across functional areas. Oversee Contract Laboratory testing. Position requires strong technical skills in combination with strong communication skills in order to meet QC objectives. Requires approximately 30 to 40% of direct time in the laboratory. Write and review CMC sections for regulatory submissions. About You: Requires Bachelor’s degree in Biochemistry, Chemistry, Biology or related field. 15+ years of relevant experience or advanced scientific degree such as a MS with 10+ years of relevant experience. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

1989 days ago