Senior In Vitro Bioassay Lead — GMP Lab

Charles River Laboratories; Ballina; On-site; EUR 40,000 - 52,000; Full time

Job summary

Charles River Ireland is seeking a skilled scientist to join our Biologics Testing Solutions team in Ballina. The role supports routine cell-based potency assays, technology transfer, and QA in a GMP environment, reporting to the Operations Manager and collaborating with scientists to advance drug development.

Responsibilities include maintaining antibiotic-free cell cultures, training team members, managing samples in LIMS, updating SOPs, handling audits, and generating GMP-compliant documents.

Qualifications

• MSc in a relevant science discipline with at least 2 years' GMP experience.
• Experience with aseptic cell culture techniques required.
• Experience in in-vitro bioassays/potency assays desirable.
• Knowledge of EU/HPRA/FDA/ICH/USP/EP guidelines.
• Ability to problem solve and work on own initiative.
• Must exhibit exceptional teamwork skills.

Responsibilities

• Maintenance and propagation of antibiotic free cell cultures.
• Competent in microscopic evaluation of mammalian cells.
• Provide technical training to team as required.
• Receipt and processing of test samples in LIMS.
• Update current standard operating procedures.
• Assist in laboratory investigations where necessary.
• Responsible for reporting progress information to Management.
• Assist in internal, regulatory and client visits/audits and respond to findings.
• Complete understanding of all regulatory guidelines.
• Liaise with the Quality Department for generation of all departmental quality documents including audit responses.
• Generation of GMP compliant SOPs, Protocols and reports
• Generate risk assessments for laboratory and test items as required.
• Maintain Laboratory Data Integrity and compliance

Skills

GMP experience

Aseptic cell culture techniques

In vitro bioassays

EU/HPRA/FDA guidelines knowledge

Problem solving

Teamwork

Education

MSc in a relevant science discipline

Job description

Charles River Ireland is seeking a skilled scientist to join our Biologics Testing Solutions team in Ballina. The role supports routine cell-based potency assays, technology transfer, and QA in a GMP environment, reporting to the Operations Manager and collaborating with scientists to advance drug development.

Responsibilities include maintaining antibiotic-free cell cultures, training team members, managing samples in LIMS, updating SOPs, handling audits, and generating GMP-compliant documents.