Description
Bio-pharmaceutical company based in Limerick is seeking a Senior QA Scientist to join there team.Summary: 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.
Essential Duties and Responsibilities include, but are not limited to, the following:
- 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
Education and Experience:
- QC Scientist: Requires Ph.D in Biochemistry, Chemistry, Biology or related field, with 3-6+ years of relevant experience.
- QC Specialist: Requires Bachelor's degree in Biochemistry, Chemistry, Biology or related field with 15+ years of relevant experience or advanced scientific degree such as a MS with 10+ years of relevant experience
A very competitive salary and benefits package is on offer for this role. If you have the relevant skill set and experience and are keen to hear more about the company and role please contact me Anna Mooney or reply with an up to date CV.