An exciting opportunity has arisen for a QC Scientist with a top biopharma company in Limerick. The QC Scientist will be required to perform assay development, characterization, optimization, transfer, validation and investigation for the QC chemistry group. You will also be required to provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.
Role of this position
- 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 and troubleshooting 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
- Requires PhD in Biochemistry, Chemistry, Biology or related field, with 2+ years of relevant experience OR MSc in Biochemistry, Chemistry, Biology or related field with 4+ years' relevant experience.
- Previous experience working in a GMP manufacturing environment is desirable.
- Experience with electronic systems such as LIMS, SoftMax, Empower, Qumas, Trackwise etc., is an advantage.
- Collaboration and team work. Maintains the highest standards of ethical behaviour.
- Strong analytical ability and associated problem solving.
Please contact Michelle Galvin today for further information on 091 373938 / firstname.lastname@example.org
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