Site Analytical Sciences Specialist — Method Lifecycle & Validation

Aphex Group; Carlow; On-site; EUR 52,000 - 68,000; Full time

Job summary

Aphex Group is seeking a Site Analytical Sciences Associate Specialist to support end-to-end method lifecycle management, including new analytical methods and transfers, within a GMP environment.

The role emphasizes technical expertise in separations and biochemistry, with responsibilities across testing, data review, investigations, and collaboration with global teams to ensure compliance and quality.

Qualifications

• Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences or related field.
• 2-3 years' experience in pharmaceutical/biotech/vaccine industry in GMP setting.
• Experience with analytical testing, data review and technical documentation.
• Experience with method validation, method transfer, compendial testing, chromatography, electrophoresis or analytical troubleshooting is advantageous.

Responsibilities

• Support/Lead analytical method transfers, validations, and compendial verifications.
• Perform laboratory-based analytical testing and technical studies using various techniques and instruments.
• 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 PQ activities and change controls in cGMP environment.
• Collaborate with QC, Manufacturing, Validation, and Global Analytical teams.
• Ensure data integrity and regulatory compliance.

Skills

HPLC/UHPLC

CE-SDS

icIEF

Empower Software

ELISA

Cell Based Assay

Data analysis

Education

Bachelor's Degree in Analytical Chemistry or related

Tools

Empower Software

Solo VPE

icIEF instrumentation

Job description

Aphex Group is seeking a Site Analytical Sciences Associate Specialist to support end-to-end method lifecycle management, including new analytical methods and transfers, within a GMP environment.

The role emphasizes technical expertise in separations and biochemistry, with responsibilities across testing, data review, investigations, and collaboration with global teams to ensure compliance and quality.