Process Analytical Scientist required for a global biotech based in Cork.
Process Analytical Scientist required for a global biopharmaceutical based in Cork. This is a permanent position.
Summary of day to day duties:
- Previous experience with potency and purity test methods for gene therapy or protein therapeutics and cell culture is highly desirable.
- Development, validation and transfer of analytical/bioanalytical methods used in QC clinical and commercial testing operations supporting in-process, release and stability testing
- Design and execution of special studies for product development activities
- Provide technical support to manufacturing, Quality and QC during manufacturing and/or QC investigations
- Support the implementation of method training to support knowledge transfer
- This position will collaborate with internal and external stakeholders to support clinical development and commercial manufacturing activities. Additionally, this position will collaborate with Regulatory and Product Quality to support CMC deliverables including content authoring and review of Quality owned sections for INDs/IMPDs, BLAs/MAAs and HA information requests and communications.
Education & Experience required:
- Minimum Degree (MSc., Ph.D.) in Chemistry, Biochemistry, Analytical Chemistry
- Minimum 5 years industry experience working with growth of multiple human, animal, and insect cell lines.
- Experience with analytical method development, validation and transfer as well as product characterization and analytical comparability
- Expert in growth of multiple human, animal, and insect cell lines is desirable.
- Familiarity with a wide range of analytical technologies such as HPLC, ELISA, and/or bioassays and analytical software such as LIMS, Empower, ChemStation, and/or Softmax Pro.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.