Role: Quality Control Microbiology Technician Location:Cork Contract role Overview Our Client is a leading biopharmaceutical company that is an industry leader in medicines in areas of unmet medical need.
With each new discovery and investigational drug candidate, they seek to improve the care of patients living with life-threatening diseases around the world.
The position will involve performing quality control testing, supporting analytical method transfers, facilitating new product introductions, and conducting technical investigations to ensure GMP compliance.
Responsibilities: Execute Bioassay techniques such as ELISA, Receptor Binding, Flow Cytometry, and Cell-based assays proficiently.
Participate in analytical method transfers and validations.
Develop expertise in assigned analytical methods.
Review test data and results to ensure they meet the required specifications and protocols.
Analyse and critically assess data quality and integrity.
Lead troubleshooting and investigations for Bioassay-related issues and technical projects.
Provide technical support for operational investigations and optimization efforts.
Introduce new technologies and contribute to continuous improvement initiatives to meet business needs.
Write and execute protocols and reports.
Develop, revise, and implement procedures to ensure compliance with regulatory standards.
Ensure consistent, efficient, and high-quality execution of analyses.
Collaborate with cross-functional stakeholders locally and across the broader Gilead network.
Manage non-routine projects and special assignments.
Required Skills & Expertise: Experience with analytical techniques including Cell Culture, ELISA, Receptor Binding, Flow Cytometry, and Cell-based assays.
Experience in method validation and method transfers is a plus.
Strong understanding of GMPs, GLPs, and regulatory requirements for Biologics testing.
Advanced skills in aseptic techniques and practices.
Proficiency with software such as Softmax Pro, LIMS, and Trackwise.
Excellent verbal and technical communication skills, with the ability to clearly explain tests, analyses, and outcomes to various audiences.
Strong interpersonal skills, with the ability to collaborate effectively with individuals across different experience levels.
Ability to work independently as well as part of a team, engaging with both internal and external partners.
Education & Experience: A minimum of 4 years of relevant experience with a BSc, or 2+ years with an MSc in Biology, Biotechnology, or a related field.
Previous experience in a Biologics testing laboratory is preferred.
Skills: Microbiology biolo Technician qc Quality Control