For 75years, 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 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 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 Qualifications 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 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. #J-18808-Ljbffr
Select how often (in days) to receive an alert: For 75years, 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 an experienced Analyst (Immunoassay) for our Analytical Services Department. The successful candidate will play a vital role, Working in a fast-paced, GMP-regulated Laboratory environment. This role is offered as a full time, Permanent role. located in Ballina, Co. Mayo What you'll be doing Reporting to the Immunoassay Supervisor this role shall be responsible for the following: Conduct immunoassays in both an R&D and GMP environment. Assist in the development and validation of different immunoassays (ELISA, Western Blot, ELISPot, etc.) and activity based assays. Generation of GMP compliant Data capture forms, SOPs, Protocols and reports. Carry out data calculations and simple statistics. Assist in internal, regulatory and client visits/audits and respond to findings Sourcing, purchasing and stocking consumables, standards and reagents required for testing. Qualifications, Knowledge, Skills and Requirements Bsc/M.Sc. in a relevant science discipline (e.g. chemistry, biochemistry, pharmacy, and biotechnology) Proven relevant experience of working in a GMP environment Must be proficient in Microsoft package particularly Excel. Must be able to work as both part of a team and on his/her own initiative Experience in the conduct of cell based assays an advantage. About RightSource (Biologics Testing) The biopharmaceutical industry is growing at an unprecedented pace which is simultaneously changing current testing methodologies. To keep up with the demand, we offer a flexible testing platform which can be deployed on-site at the client site to their exact needs. Our biologics testing lab...in a box…at the client site. RightSource℠ is completely managed and operated using our quality management system, SOP’s, methods, and best practices. It’s as if you shipped your samples to an outsourced lab but walked down the hall instead. Our Biologics Testing Solutions offers a variety of services such as contamination and impurity testing, protein characterization, 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. 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. 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 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 fostering a sense of belonging and work daily in this direction. For more information, please visit www.criver.com. #J-18808-Ljbffr
A global biotechnology firm in Ballina is seeking an experienced Analyst (Immunoassay) to join their Analytical Services Department. This full-time position involves conducting immunoassays and assisting with the development and validation of various assays in a fast-paced GMP-regulated laboratory. Candidates should hold a relevant science degree and have experience in a GMP environment, along with proficiency in Microsoft Excel. Join a team that plays a vital role in advancing health globally. #J-18808-Ljbffr
Select how often (in days) to receive an alert: For nearly 75years, 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 The Business Optimisation Lead, reporting to the site director, is responsible for continuous improvement and optimisation at the CRL Dublin site through ownership and management of the project portfolio. The Business Optimisation lead will engage the management team in regular reviews of the portfolio, identifying and managing projects through the project lifecycle to ensure prioritization and focus is placed on the key areas in line with site goals and strategy. The Business Optimisation lead is also the site subject matter expert (SME) on project management and sets standards and practices for project development, execution and delivery as well as for general project lifecycle management. As SME they will coordinate with global functions responsible for project management to ensure alignment of the Dublin approach with both microbial sites in the network and global CRL best practice standards. As the site lead for continuous improvement and optimisation a key responsibility will be to manage the site continuous improvement program. Collaborating with the site departments and leadership team identify and drive improvement opportunities in their areas through structured projects. DUTIES & RESPONSIBILITIES Manage site continuous improvement program Coordinate training and mentoring of improvement projects. Develop and manage the site portfolio of projects. Lead and execute the portfolio management process. Act as subject matter expert (SME) on project management. Develop and manage the site improvement program. Drive improvement projects within the portfolio to deliver ongoing continuous improvement. Lead and coach teams implementing improvement projects. Manage and coordinate improvement training on site Coordinate people and resources to execute and deliver projects within a specified timeline. Communicating on PM Status both on site and within wider CRL network. Lead key projects from inception to completion according to a set timeline and budget. Work with leadership team to identify and eliminate blockers and potential risks. Serving as a point of contact for teams when multiple units are assigned to the same project to ensure team actions remain in synergy. Develop a culture of improvement and optimisation on site. Job Qualifications Bachelor’s degree or equivalent A demonstrable track record of experience in a Business Improvement or Project Management role Qualification in project management Certification / training and or experience in improvement methodology – Lean, Agile etc., Strong analytical and problem‑solving skills. Excellent communication, influencing and interpersonal skills. Proven ability and passion for improvement Ability to lead and motivate teams. Knowledge of performance metrics and data analysis. Strong stakeholder management, communication and relationship building skill Experience in leading and delivering projects (ideally in a regulated environment) Excellent collaborator with cross functional customers and network partners Strong knowledge of portfolio management tools and reporting platforms, e.g. Power Bi, MS Project About Microbial Solutions Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever‑changing needs of the industry. We help clients to ensure product safety and quality with easy‑to‑use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies. 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past 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. #J-18808-Ljbffr
A leading contract research organization in Dublin is seeking a Business Optimisation Lead to enhance project management and continuous improvement efforts at the site. You will oversee project portfolios, collaborate with teams to identify improvement opportunities, and ensure alignment with global best practices. Ideal candidates should have a Bachelor’s degree, experience in project management, and strong communication skills. This role plays a crucial part in driving operational excellence and optimization initiatives, contributing significantly to health and safety in drug development. #J-18808-Ljbffr
A leading contract research organization based in Ballina is seeking a Quality Assurance Manager to establish and manage QA programs. This full-time on-site role involves ensuring compliance with regulatory standards, developing SOPs, and leading inspections and audits. The ideal candidate will have a Bachelor's degree in relevant sciences, strong leadership skills, and experience in the pharmaceutical industry. Opportunities for domestic and international travel may be required. Competitive salary and benefits offered. #J-18808-Ljbffr
Location: Ballina, IE, F26D786 For 75years, 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 Responsible for establishing and managing the Quality Assurance programs in support of the Manufacturing business. Serves as a member of the Quality and Compliance management team. Provides direction in implementing the Charles River Compliance Program and coordinates with peers to promote consistency in quality assurance operations, regulatory interpretation, and processes. Works with the operational teams to assure regulatory compliance and consistency with Charles River policies and procedures. This key role is based in our Ballina facility Co. Mayo and will be functional on-site in a full-time capacity. This role may also require occasional domestic and international travel. Essential duties and Responsibilities Establish and manage the Quality Assurance program in support of Charles River, ensuring compliance and harmonisation with Charles River policies and procedures. Develop and maintain all required SOP’s, documents, forms, and documentation required to support business operations. Communicate all identified compliance and quality risks to his/her supervisor. Develop quality assurance policies and procedures to ensure applicable regulatory requirements are fulfilled. Identify the need for, and assist in the development of, Corporate and Business Unit Quality and Compliance Policies. Manage Quality Assurance operational groups to assure inspections and audits are accurate, thorough, timely, and provide the correct interpretation of regulatory requirements and corporate policies. Assure staff receive appropriate regulatory and management training and mentoring to enable the execution of regulatory and management responsibilities. Assume a lead role in the development and presentation of regulatory training for Quality Assurance and operations staff. Monitor the effectiveness of subordinate personnel in managing compliance systems and assuring the timely completion of: (1) review and approval of records and reports; (2) inspections of facilities and equipment; (3) investigations, (4) audits of methods, practices, and controls; and (5) Regulatory Affairs and Compliance projects and programs. Identify and resolve any scheduling conflicts and program priorities to assure timelines are fulfilled. Monitor the effectiveness of subordinate Quality Assurance personnel in reviewing Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies. Identify and resolve inconsistencies between Quality Assurance audit teams should they occur. Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements. Serves as a liaison with operations managers to identify regulatory deficiencies, explain audit findings, resolve conflicts, and consult on corrective and preventative actions. Essential duties and Responsibilities continued Assemble, evaluate, and report group metrics measuring compliance and quality key performance indicators. Represent the corporation during regulatory and client inspections/audits. Prepare site/operation personnel for client and regulatory audits and prepare appropriate summaries and reports of such audits. Lead the preparation of regulatory and client audit responses and corrective action commitments. Monitor site/operation corrective actions commitments and communicate “at risk” commitments to management with recommendations for their timely resolution. Identify practices, methods, and processes for improvement and assist other operations on related compliance issues. Assure vendors and suppliers identified/designated by Charles River are assessed for compliance with applicable regulatory requirements. Participate in Quality and Compliance projects and programs. Participate in Corporate Quality Meetings, Regulatory Affairs and Compliance meetings, intranet communications, and relevant strategic planning sessions. Assure that Corporate Quality and Compliance Policies are implemented and administered at the site/operation. Direct activities of assigned group(s) to ensure optimum performance of the group/function. Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews. Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans. Integrate activities with those of other major organizational units (e.g., segments, departments, functions). Develop and recommend departmental budget and authorise expenditures. Develop and oversee the implementation of departmental training programs, including orientation. Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols]. Communicate all identified compliance and quality risks to his/her supervisor. Performs all other related duties as assigned. Qualifications, Requirements and Competencies Education : Bachelor’s degree (B.A. /B.S.) or equivalent. Advanced degree in biological sciences, pharmaceutical sciences, or computer sciences preferred. Experience : Seasoned and related experience in the GMP pharmaceutical and/or biotechnology-based industry. Leadership : Proven experience in leading teams implementing practices that improve efficiency. Demonstrates strong leadership ability, communication, and facilitation skills with both internal Charles River and external client personnel. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Strong experience and direct responsibility for management of Quality Assurance programs and creating new programs and processes. Experience with direct management of QA audits and inspections as well as interfacing with clients and regulatory agencies and preparing/reviewing responses to any inspectional findings. Strong knowledge of pertinent national and international regulations pertaining to the pharmaceutical and biotechnology industries. Strong knowledge of computerised system compliance, validation, and data integrity requirements. Skilled in process optimisation and continuous improvement. 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. Job Segment: Pharmaceutical, Quality Assurance, Laboratory, Biology, Biotech, Science, Technology #J-18808-Ljbffr
