Senior In Vitro Bioassay Analyst

Charles River Laboratories; Ballina; In loco; EUR 40.000 - 52.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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

Conoscenze

GMP experience

Aseptic cell culture techniques

In vitro bioassays

EU/HPRA/FDA guidelines knowledge

Problem solving

Teamwork

Formazione

MSc in a relevant science discipline

Descrizione del lavoro

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

This role shall report to the CBA Operations Manager 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 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.
• 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 (e.g. cell morphology, count and viability)
• 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

Job Description

Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements. Executes scientific testing strategies and studies. May participate in development as part of team. May lead assay research, assay validation or study conduct, or is involved in preparation of material (e.g. protein, nucleic acid, cells, etc.). Reviews and interprets study data, communicates results to clients and writes final reports. Ensures compliance with protocols and all applicable SOPs. Troubleshoots and resolves assay or technical issues in the laboratory when scientific expertise is needed. Contributes to specific dataset interpretation, or when appropriate answering questions from regulatory authorities. For singular focus of Chemistry or Biology disciplines, refer to specified role on job architecture.

Job Qualifications

• 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 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.