Analytical Scientist - Drug Product Forensics & Defects - 16/5 shift pattern

Office/Project Location: Dún Laoghaire, Dublin

Employment Type: 12-Month Contract

Pay: Hourly Rate €30-€35

Experience: 3-6+ years' postgraduate experience

Visa: EU passport or Stamp 4 visa required

Our client is a global biopharmaceutical leader specializing in the development, manufacturing, and supply of innovative human therapeutics.

A Commercial Attribute Sciences Senior Associate is required on a 12-month contract within the Process Development Commercial Attribute Sciences (CAS) Department at their advanced manufacturing facility in Dún Laoghaire, South Dublin.

Operating on a 16/5 shift cycle with hybrid flexibility (1 day per week remote), this role will support the Forensics and Defects team. The successful candidate will lead forensic investigations into finished drug product defects and manage the extensive defect panels used for qualification, training, and operation of automated and manual visual inspection systems.

Lead and assist in forensic laboratory investigations for particulate and defect identification arising from drug product fill-finish operations (vials, lyophilized products, pre-filled syringes)

Author comprehensive, cGMP-compliant technical investigation reports, laboratory deviations, root cause analyses, and Post-Market Alert Files (PMAFs)

Manage, curate, distribute, and maintain extensive defect panels used for characterization, qualification, and routine setup of manual and automated visual inspection equipment

Accurately record analytical test data within Electronic Laboratory Notebook (ELN) and Laboratory Information Management Systems (LIMS), adhering strictly to ALCOA+ data integrity standards

Participate in peer review of analytical data, test logs, and investigative findings across cross-functional teams

Execute routine and non-routine analytical testing using spectroscopic, microscopic, and physical characterization techniques

Ensure rigorous laboratory compliance with Standard Operating Procedures (SOPs), safety policies, and environmental sustainability practices (MyGreenLab® initiatives)

Support preparation for internal quality audits and external regulatory agency inspections (HPRA/FDA)

Interface with manufacturing operations, quality assurance, packaging engineering, and process development groups to drive right-first-time root cause resolutions

Requirements

Degree (Level 8) in Analytical Chemistry, Biochemistry, Forensic Science, Chemical Engineering, or a related pharmaceutical discipline

3-6+ years' post-graduate laboratory experience within a cGMP pharmaceutical or biopharmaceutical manufacturing environment

Demonstrated experience in particulate analysis, visual inspection defect categorization, or forensic characterization of drug products

Hands-on understanding of data integrity governance, change control, and laboratory deviation handling

Proficiency with root cause problem-solving methodologies and statistical data evaluation tools

Excellent technical writing, reporting, and inter-departmental communication skills

Willingness to support a 16/5 shift pattern based out of Dún Laoghaire, South Dublin

Package

Hourly rate €30-€35

12-month contract

Hybrid working (1 day per week remote)

16/5 shift pattern

Contact

Karen McHugh is the consultant managing this position.

If you are a Analytical Scientist interested in roles based in Dublin, you can contact Karen by e-mail at karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Analytical Scientists in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.

TAGLIFE