For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

We are seeking a Senior In-Vitro Bioassay Analyst to work in our Biosafety & Cell Based Assay Department located in Ballina, Co. Mayo, Ireland.

We are looking to recruit a Senior In-Vitro Bioassay Analyst, who along with a Laboratory Supervisor and Junior analysts will be responsible for expanding the laboratory to GMP standards. The team will be responsible for the development and validation of new cell based potency assays (CBA) for clients, execution of routine validated CBAs and for day to day running of the laboratory. All new roles will be involved in both the culture of cells and in performing the end-point analysis e.g. . colorimetric assays, ELISA, PCR, Flow cytometry.

This role shall report to the Biosafety & Cell Based Assay Supervisor and the main duties & responsibilities shall be to assist the Department Manager and/or the Scientist in the following:

• Leading the execution of routine cell based potency assays
• Support the technical transfer of new cell based assays
• Maintenance and propagation of antibiotic free cell cultures.
• Evaluation of mammalian cells / Generation and maintenance of mammalian cell banks.
• Establishment of Test Method SOPs and validation of methods
  
  

Core duties shall include:

• Maintenance and propagation of antibiotic free cell cultures.
• Competent in microscopic evaluation of mammalian cells and viral infections (e.g. CPE, Plaque assays, haemadsorption)
• 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 off all regulatory guidelines.
• Liaise with the Quality Department for the generation of all departmental quality documents including audit responses, facility replies and deviation reports.
• Generation of GMP compliant SOPs, Protocols and reports
• Generate risk assessments for laboratory and test items as required.
• Maintain Laboratory Data Integrity and compliance
  
  

Profile And Requirements

The following are minimum requirements related to the Senior In-Vitro Bioassay Analyst position

• MSc in a relevant science discipline (A minimum of 2 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry).
• Experience of aseptic cell culture techniques mandatory.
• Experience in in-vitro bioassays/potency assays highly desirable.
• Knowledge of current EU/ HPRA/ FDA/ICH/USP/EP guidelines
• Ability to problem solve and work on own initiative.
• Must Exhibit exceptional teamwork skills.
  
  

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterzation, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.