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 an experienced Laboratory Operations lead to work in our Biosafety and Cell Based Assay Laboratory located in Ballina, Co. Mayo, Ireland.
The preferred candidate will have demonstrable knowledge of laboratory safety and laboratory equipment in a GMP setting and will be instrumental in planning, directing and implementing improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory.
This role shall report to the Biosafety & Cell Based Assay Manager and the main duties & responsibilities shall be to:
- Manage the daily operation of the laboratory, ensuring efficient workflow, appropriate allocation of tasks, and maintenance of high operational standards
- Ensure the laboratory maintains compliance and adherence to Good Manufacturing Practices (GMP)
- Manage laboratory Health & Safety, including risk assessments, COSHH, internal safety audits, and promoting a culture of good laboratory practice and safe working
- Oversee stock maintenance, procurement and supplier approval
- Coordinate internal/client/regulatory audits of the laboratory area
- Liaise with the Quality Department on audit responses, facility replies and equipment OOL / deviation reports
- Oversee maintenance of all laboratory equipment in coordination with Calibration /Validation team
- Communicate with external engineers / contractors
- Generation of / Updating GMP compliant SOPs
Job Qualifications
- Bachelor’s degree in Pharmaceutical Science, Cell Biology / Molecular Biology or a related science
- 3+ years’ experience in a fast-paced GMP Lab
- Must be able to work as an integral part of a broader team with QA, QC, Validations, Procurement, etc
- Excellent communication skills and a good problem solver
- Experience of managing people is preferable
- Detail-oriented with a high level of accuracy
- Ability to deal with people at all levels including internal and external clients
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.