Associate Specialist/Specialist, Site Analytical Sciences (SAS)

Aphex Group

Carlow

On-site

EUR 52,000 - 68,000

Full time

11 hours ago

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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

Purpose
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.

Key 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.

Qualifications & Experience

Education

Bachelor's Degree in Analytical Chemistry, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline.

Experience

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