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 Reporting to the Analytical Technical Operations Manager, this role will be responsible for the Immunoassay area within the Analytical Department.
A team of 8-10 Analysts will report to this role.
We are seeking an experienced Immunology Supervisor for our Biologics Division located in Ballina, Co. Mayo, Ireland.
This main duties & responsibilities will be: Oversee the quality of work produced by the Immunoassay team and ensure it is conducted in accordance with Standard Operating Procedures and the principles of GMP.
Implement and supervise safe working methods within the team and to inform and instruct staff of these.
Comply with all Health and Safety regulations and procedures.
Develop, co-ordinate and implement training for staff on technical aspects of new and existing assays.
Provide feedback on performance to analysts working on Client specific projects.
Be involved in preparing costings and proposals based on protocols/project plan of proposed work by clients.
Assist in the transfer of assays from clients to Analytical Services Department where appropriate.
Participate in regulatory and client audits and liaising with clients as required.
Assist in the generation of appropriate SOPs Assist Project Leaders in research technical information for incoming new enquiries.
Compile audit responses in conjunction with the team and the Analytical Technical Operations Manager.
Support staff with deviations and laboratory investigation reports.
Raw data review.
Ensure all raw data and test results are retained and archived according to current SOP's.
Assist in Test Item Receipt (LIMS), Storage, Disposal and Decontamination.
Job Qualifications The following are minimum requirements related to the Immunoassay Supervisor position.
BSc.
In a relevant science discipline (e.g.
Chemistry, Biochemistry or Biotechnology) A minimum of 3 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
Proven track record of supervising/managing staff.
Experience in analytical techniques (e.g.
ELISA, Western Blot) essential.
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 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.