Analytical Technology Specialist – Mayo

Desired Skills: elisa,cell culture,potency assay

PE Global are currently recruiting for  Analytical Technology Specialists for our client site in Mayo on a 12-month initial contract:

Fully onsite

The Bioassay Department is seeking a highly skilled Analytical Technology Specialist for a 12-month contract. This role is integral to supporting the NPI group’s activities in release and stability testing for products in development. The specialist will perform Cell Based Potency Assay (CBPA) and ELISA testing for both development and clinical products generated by Biologics Development Manufacturing. Additional responsibilities include new method transfers, validations, and maintaining laboratory operational excellence. Previous experience in a cGMP/GLP environment is highly advantageous.

Responsibilities

• Support NPI QC Testing on Primary Stability Batches, Clinical, Pre Performance Qualification, Demo, and investigational lots using Cell Based Potency Assay and ELISA methods
• Timely review of testing records and all associated documentation
• Conduct routine laboratory duties such as critical reagent qualifications, inventory management, and equipment maintenance
• Ensure all activities adhere to regulatory (QA and EHS) and corporate requirements
• Open and progress QMS records as needed (Laboratory Investigations, Change Controls)
• Complete assigned training in a timely manner
• Maintain laboratory data integrity by understanding applicable regulations and business processes
• Provide input on assay performance monitoring and trending
• Support Root Cause Analysis Investigations
• Participate in departmental and Tier meetings

Qualifications

• Bachelor’s, Master’s, or Ph.D. in Biological Science with 1-3 years of QC GMP experience
• Practical experience in mammalian cell culture and basic techniques (passaging, freeze-down, drug treatments) is an advantage
• Strong scientific and practical understanding of ELISA-based methods
• Proven problem-solving skills
• Clear communication skills
• Good organizational and interpersonal skills
• Willingness to up-skill and collaborate
• Ability to lead and drive projects to meet timelines
• Focus on Right First Time (RFT)

Interested candidates should submit an updated CV, marked for the attention of Audrey

audrey.mccarthy@peglobal.net  or  00353 21 4297900