This top biopharmaceutical organisation have been developing and manufacturing an extensive portfolio of healthcare products for over 125 years, supplying markets worldwide with life-saving therapies and vaccines. With the introduction of one of their blockbuster drugs to a recently acquired manufacturing facility in North Dublin, the Bioassay Specialist will be responsible for ensuring efficient and effective compliant design, construction, qualification, and operation of the new Bioassay lab.

The Role

Responsibilities of the Bioassay Specialist will include:

• Qualifying the Bioassay analytical lab and the transfer of Bioassay analytical methods
• Ensuring the process is streamlined and in line with company lean methodologies
• Supporting the complete analytical lab build
• Performing activities for general lab readiness, laboratory equipment qualification and method transfers
• Performing and carry out a variety of analytical techniques including but not limited to Potency Elisa test in compliance with GMP requirements
• Following up-to-date analytical practices with reference specifications, regulations and industry standards
• Planning and maintaining the laboratory testing schedule to achieve an efficient QC system
• Maintaining good housekeeping and hygiene within the laboratory
• Participating in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures
• Ensuring training is current for all job functions performed

The Person

The successful candidate will have skills and experience in the following:

• Science/Quality/Technical degree qualification. Masters preferred
• 3-5 years' relevant industry experience in a bio/pharma/GMP environment
• Experience in the Elisa method and other relevant analytical techniques
• Working knowledge of QC Systems (EN, LIMS) and Trackwise
• Knowledge of method transfer & validation
• Desirable evidence of Continuous Professional Development
• Excellent troubleshooting and problem-solving skills
• Ability to respond to changing priorities
• Preference Lean Six Sigma

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.