Analytical Technology Specialist

PE Global; Westport; On-site; EUR 55,000 - 75,000; Full time

Job summary

PE Global is currently recruiting for an Analytical Technology Specialist for a leading multi-national Pharma client based in Westport.

This contract role supports the NPI group’s release and stability testing, performing Cell Based Potency Assay (CBPA) and ELISA on development and clinical products with emphasis on cGMP/GLP compliance.

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 is an advantage.
• Strong scientific and practical understanding of ELISA-based methods.

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.

Skills

Cell culture

ELISA-based methods

Problem solving

Organizational skills

Interpersonal skills

Project leadership

Right First Time (RFT)

Education

Biological Science (BSc/MSc/PhD)

Job description

PE Global is currently recruiting for a Analytical Technology Specialist for a leading multi-national Pharma client based in Westport.

This is a contract position.

Role:

The Bioassay Department is seeking a highly skilled Analytical Technology Specialist. 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

Requirements:

• 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
• 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

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***