In-Vitro Bioassay Analyst

Charles River Laboratories; Ballina; On-site; EUR 38,000 - 52,000; Full time

Job summary

Charles River is seeking an In Vitro Bioassay Analyst to join the Biosafety & Cell Based Assay Department in Ballina, Co. Mayo, Ireland.

The role reports to the CBA Operations Manager and involves executing routine cell-based potency assays and supporting transfer, qualification and validation of new cell-based assays. You will maintain and propagate antibiotic-free cell cultures, assist in lab investigations and help generate GMP-compliant SOPs and reports.

Qualifications

• Bachelor's degree in biology or biochemistry or equivalent.
• Minimum 1 year of GMP-regulated lab experience is highly desirable.
• Experience with aseptic cell culture techniques is desirable.
• Experience with in vitro bioassays is desirable.
• Familiarity with regulatory guidelines is an advantage.

Responsibilities

• Execute routine cell-based potency assays.
• Support transfer, qualification and validation of new cell-based assays.
• Maintain and propagate mammalian cell cultures.
• Generate and maintain mammalian cell banks.
• Complete laboratory investigations as needed.
• Assist in generating GMP-compliant SOPs, protocols and reports.
• Ensure data integrity and compliance in the laboratory.

Skills

Cell culture

GMP experience

Analytical thinking

Problem solving

Education

BSc in Biology or Biochemistry

Tools

LIMS

Microscopy

Job description

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 Overview

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

This role shall report to the CBA Operations Manager and the main duties & responsibilities are as follows:

• Execution of routine cell-based potency assays
• Support technical transfer, qualification and validation of new cell-based assays
• Maintenance and propagation of antibiotic free cell cultures.
• Evaluation of mammalian cells / Generation and maintenance of mammalian cell banks.

Core Duties Shall Include

• Maintenance and propagation of antibiotic free cell cultures.
• Competent in microscopic evaluation of mammalian cells (e.g. cell morphology, count and viability)
• Receipt and processing of test samples in LIMS.
• Support update current standard operating procedures.
• Assist in laboratory investigations where necessary.
• Support generation of GMP compliant SOPs, Protocols and reports
• Generate risk assessments for laboratory and test items as required.
• Maintain Laboratory Data Integrity and compliance.

The following are minimum requirements related to the In Vitro Analyst position.

• BSc in a relevant science discipline (e.g. Biology, Biochemistry, etc.)
• A minimum of 1 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry is highly desirable.
• Experience of aseptic cell culture techniques desirable.
• Experience in in-vitro bioassays highly desirable.
• Basic understanding off regulatory guidelines desirable.
• Ability to problem solve and work on own initiative.

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 80% of the drugs approved by the FDA in the last five years.

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.