SENIOR QC SPECIALIST required by CareerWise Recruitment for our multinational BioTech client in Limerick. This is a permanent role.
The SENIOR QC SPECIALIST will perform assay development, characterization, optimization, transfer, validation and investigation for QC chemistry group. 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 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 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.
Please call Conor Twomey today for further information on 021 4297422 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)