Assoc. Spclst, Quality Control

Job Overview

A fantastic opportunity has arisen for an Associate Technical Specialist Biochemistry & Cell Biology in our Dunboyne facility. This individual will be responsible for quality control support testing by providing technical expertise for the following activities: method execution troubleshooting, establishment of methods, input in investigations, building capability related to Biochemistry and Cell Biology methods and Analytical methods.

Key Responsibilities

• Develop lead and coach the Quality Control team in relation to the technical aspect of the lab activities and drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
• Support the performance and optimisation of advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.
• Perform advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.
• Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Area Lead.
• Works under minimal supervision.
• Prepare and update SOPs as required.
• Drive the development of technical skills through coaching and motivate a high performing culture across the team.
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness, health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
• Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.
• Support the preparation of laboratory protocol studies/validations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA and cGMP regulations.
• Consistently deliver on specific area Key Performance Indicators.
• Foster a continuous improvement environment and bring strong problem solving and troubleshooting capabilities.

Required Qualifications

• A Master's degree qualification in Science/Quality/Technical disciplines with 5 years' experience in the biotechnology and/or pharmaceutical industry, (preferably both) Or PhD with 3 years' experience.
• Leadership skills and experience managing daily activities.
• Preferably Lean Six Sigma experience.
• Excellent written and oral communication skills.
• Strong understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Required to work on their own initiative in a constructive manner in addition to working as part of a team.
• Excellent time management and organisational skills.
• Strong understanding of biochemical and cell biology methodology (ELISA, SDS-Page, Bio-Assays, PCR, and compendial assays, e.g. pH, Appearance, TOC etc) and strong technical skills.
• Strong understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
• Experience with continuous quality/process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).

Job Details

• Location: Dunboyne facility.
• Employee Status: Regular
• Relocation: No relocation
• VISA Sponsorship: No
• Travel Requirements: No Travel Required
• Flexible Work Arrangements: Not Applicable
• Shift: Not Indicated
• Valid Driving Licence: No
• Hazardous Material(s): NA
• Job Posting End Date: 08/22/2026
• Hybrid Working Model for office-based colleagues around the world.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.