QC Bioassay Analyst II

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

Job summary

A leading biopharmaceutical company in Cork is looking for a QC Bioassay Analyst II to conduct quality control testing and analytical method transfers. The role involves executing Bioassay techniques such as ELISA and Receptor Binding, along with participating in method validations. Candidates should possess advanced skills in aseptic techniques and analytical methods, ensuring compliance with GMP and regulatory standards. Excellent communication and interpersonal skills are essential for effective collaboration with diverse stakeholders.

Qualifications

• Experience with analytical techniques such as Cell Culture, ELISA, and Receptor Binding.
• Experience in method validation/method transfers is a plus.
• Knowledge of GMPs, GLPs, and regulatory requirements.

Responsibilities

• Execute Bioassay techniques for quality control testing.
• Participate in method transfers and validations.
• Review data to ensure compliance with specifications.

Skills

Bioassay techniques

Cell Culture

ELISA

Receptor Binding

Data Analysis

Interpersonal skills

Aseptic techniques

Tools

Softmax Pro

LIMS

Job description

This QC Bioassay Analyst II role will include quality control testing and analytical method transfers 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
• Participate in Bioassay investigations/troubleshooting and technical projects within the function
• Deliver new technologies and continuous improvement initiatives to meet business requirements
• Execute protocols and reports
• 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 theilead 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
• 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