QC NPI Analyst - HPLC - Biotech - Dublin

Office/Project Location: Dun Laoghaire, Dublin

Employment Type: Contract

Pay: Hourly Rate €30 - €35 per hour (OT/DT Eligible)

Experience: 2-3 years' biopharmaceutical QC or cGMP laboratory experience

Visa: EU passport or Stamp 4 visa required

Our client is a global biopharmaceutical manufacturing leader operating major commercial production and development facilities in Ireland.

The QC Senior Associate (New Product Introduction - NPI) is required to act as the primary QC representative for NPI activities and routine product introduction meetings.

Based fully onsite 5 days a week, they will plan and execute non-core analytical testing, manage NPI sample workflows, author site documentation, and coordinate lab data within LIMS—supporting QC, Process Development, and commercial manufacturing operations.

Act as the dedicated Quality Control Representative for NPI activities, project groups, and cross-functional site product meetings

Plan and execute non-core and complex routine/non-routine analytical testing for NPI transfers (e.g., HPLC, rCE-SDS, Sub-Visible Particles, Protein Concentration/Content)

Manage E2E sample management activities and LIMS data coordination for all NPI streams across the site

Create, own, and update NPI sample plans, standard operating procedures (SOPs), and technical GMP documentation

Report, evaluate, trend, archive, and approve analytical test data, ensuring "Right First Time" compliance

Initiate, lead, and review lab investigations (OOS/OOT), root cause analyses, and change controls for NPI methods

Generate APPX data files and randomization memos to support statistical data analysis and regulatory filing support

Evaluate lab practices continuously against cGMP, Data Integrity standards, and global quality requirements

Participate in internal compliance audits, continuous improvement projects, and regulatory agency inspections

Requirements

Bachelor’s degree (Level 8) in Science, Chemistry, Biotechnology, or a related discipline

2-3 years' biopharmaceutical QC or cGMP laboratory experience in a pharmaceutical environment

Hands-on proficiency with analytical techniques: HPLC, rCE-SDS, Sub-Visible Particle analysis, and Protein Content assays

Demonstrated expertise in Data Integrity principles, cGMP regulations, Thermo LIMS, and technical writing (investigations, SOPs, change controls)

Strong analytical troubleshooting skills with the ability to work independently under minimal supervision

Flexibility to support extended hours or weekend work as required by project delivery milestones (potential introduction of a 2-cycle shift pattern in 2027)

Package

Hourly Rate €30 - €35 per hour depending on experience

Overtime (OT) and Double Time (DT) pay eligibility

Initial 12 month contract duration with strong potential for extension

Onsite Expectations: Must be onsite 5 days a week

Contact

Karen McHugh is the consultant managing this position.

If you are a QC NPI Senior Associate interested in roles based in Dublin, you can contact Karen by e-mail 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 QC NPI Senior Associates in Dublin and Ireland.

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

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