The role:
PE Global is currently recruiting for an Analytical Scientist on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role.
Description:
The Site Analytical Sciences Associate Specialist/Specialist role is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations and biochemistry.
Responsibilities:
- Support/Lead analytical method transfers, validations, and compendial method verifications.
- Perform laboratory-based analytical testing and technical studies using a variety of analytical techniques and instrumentation.
- Generate, review, interpret, and verify analytical data and technical documentation.
- Support lifecycle management and continuous improvement of analytical methods.
- Assist with troubleshooting of analytical methods and laboratory equipment.
- Support equipment performance qualification activities (PQ).
- Participate in laboratory investigations, deviations, CAPAs, and change controls.
- Collaborate with Quality Control, Manufacturing, Validation, Technical Operations, and Global Analytical teams.
- Ensure compliance with cGMP, data integrity, safety, and regulatory requirements.
- Supporting digital method development.
Education and Experience:
- Bachelor's Degree in Analytical Chemistry, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline.
- Minimum 2-3 years' experience within the pharmaceutical, biotechnology, or vaccine industry.
- Experience working in a GMP-regulated laboratory environment.
- Experience with analytical testing, data review, and technical documentation.
- Experience with method validation, method transfer, compendial testing, chromatography, electrophoresis, ELISA or analytical troubleshooting is advantageous.
Desired Technical Skills:
- HPLC/UHPLC (Agilent/ Waters)
- CE-SDS (AB Sciex instruments)
- icIEF (Maurice, Biotechne)
- Empower Software Competency
- Solo VPE
- ELISA
- Cell Based Assay
- Compendial testing and Method Verifications
- Data analysis and technical report writing
- Laboratory investigations and root cause analysis
- GMP documentation and data integrity practices
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***