Our client, a global biopharmaceutical leader, is seeking an experienced Senior Scientist - Analytical Science & Technology to join their global testing hub at their state-of-the-art facility in Meath.
You will provide analytical expertise to support the global testing laboratory for Biologics, coordinate and provide assistance for analytical method development, optimisation, validation and analytical technical transfers, assist in the authoring of regulatory submissions, and lead investigations and problem-solving activities with site QC teams and partners from global QC.
Duties and responsibilities of the Analytical Science & Technology Senior Scientist will include:
- Assist in the execution of cGMP compliant and timely transfer of analytical methods into the QC labs at the site (Analytical, Biochemical, Cell Biology, Microbiology and Raw Materials)
- Provide analytical technical expertise and oversight within the QC labs
- Act as the technical expert to support new method introduction and continuous analytical innovation in the lab
- Support new product introduction by ensuring required analytical instrumentation is procured, installed & qualified as per GMP requirements
- Act as local SME for relevant global procedures (e.g. Method validation and transfer, control chart trending, handling of investigations)
- Identify, lead and drive improvements or remediation for analytical Assays (OOS, CAPA, etc)
- Support Regulatory Audits and assure inspection readiness
You will have skills and experience in the following:
- Ph.D. in a technical discipline is required (e.g. biochemistry, chemistry, Analytical science, cell biology)
- At least 3-5 years experience in the biotechnology and/or pharmaceutical industry, with Operational experience of quality laboratories & demonstrated project management experience
- Experience of analytical transfer programs and method development/validation
- A background in analytical methods (PCR, HPLC, ELISA, SDS-Page, Glyco analytic, Bio-Assays, PCR, capillary electrophoresis and compendial assays)
- Experience leading root cause analysis and effective investigation practices
- Excellent collaboration skills and teamwork mindset
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.