QC Bioassay Analyst III

Gilead Sciences; Cork; On-site; EUR 50,000 - 70,000; Full time

Job summary

A biopharmaceutical company in Cork seeks a QC Bioassay Analyst III. You will handle quality control testing and method transfers, ensuring compliance with specifications. Key responsibilities include leading investigations, developing procedures, and delivering new technologies. The role requires experience with analytical techniques and excellent communication skills. Join our team to support GMP operations and contribute to continuous improvement initiatives.

Qualifications

• Experience with analytical techniques including Cell Culture and ELISA is required.
• Knowledge of GMPs and regulatory requirements for Biologics testing.
• Previous industry experience is essential.

Responsibilities

• Execute Bioassay techniques such as ELISA and Cell-based assays.
• Lead Bioassay investigations and technical projects.
• Develop and implement procedures complying with regulatory requirements.

Skills

Cell Culture

ELISA

Receptor Binding

Cell-based assays

Aseptic techniques

Communication skills

Interpersonal skills

Education

Bachelor's degree in a relevant field

Tools

Softmax Pro

LIMS

Job description

This QC Bioassay Analyst III role will include quality control testing, analytical method transfers, new product introductions and technical investigations to support our GMP operations

Specific Job Responsibilities

• Proficiently execute Bioassay techniques such as ELISA, Receptor Binding and Cell‑based assays
• Participation in analytical method transfers/ method validations
• Develop subject matter expertise on assigned analytical techniques
• Review data and results of testing to ensure compliance to appropriate specifications and protocols
• Demonstrate skills in data analysis and ability to critically evaluate data quality
• Lead Bioassay investigations/troubleshooting and technical projects within the function
• Provision of technical support for investigations and optimisation projects
• Deliver new technologies and continuous improvement initiatives to meet business requirements
• Execute protocols and reports
• Develop, revise, and implement procedures that comply with appropriate regulatory requirements
• Execute analysis efficiently, consistently, and with high quality
• Interface with key cross functional stakeholders locally and across the Gilead network
• Work on non‑routine projects and assignments

Skills & Expertise

• Experience with analytical techniques such as Cell Culture, ELISA, Receptor Binding and Cell‑based assays is required
• Experience in method validation/ method transfers is an advantage
• Working knowledge of GMPs, GLPs, and regulatory requirements for Biologics testing
• Advanced skills in proper aseptic techniques and behaviours
• Knowledge of software such as Softmax Pro, LIMS
• Excellent communication skills (both verbal and technical) – demonstrates the ability to clearly and concisely present/explain tests, analysis, and outcomes to multiple audiences
• Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience
• Ability to work independently and as part of a team with internal and external partners
• Previous Industry experience is required