We are a leading contract research organization with 75 years of experience in assisting the discovery, development, and safe manufacture of new drug therapies. Our employees play a significant role in the health and well-being of people across the globe.
Job Summary
This role will report to the Biosafety & Cell Based Assay Supervisor and involve assisting the Department Manager and/or Scientist in:
* Leading routine cell-based potency assays
* Supporting technical transfer, qualification, and validation of new cell-based assays
* Maintaining and propagating antibiotic-free cell cultures
* Evaluating mammalian cells and generating/maintaining mammalian cell banks
* Establishing Test Method SOPs and validating methods
Main duties include:
* Maintenance and propagation of antibiotic-free cell cultures
* Competence in microscopic evaluation of mammalian cells (e.g., cell morphology, count, and viability)
* Providing technical training to the team as required
* Receipt and processing of test samples in LIMS
* Updating current standard operating procedures
* Assisting in laboratory investigations where necessary
* Responsible for reporting progress information to Management
* Assisting in internal, regulatory, and client visits/audits and responding to findings
* Complete understanding of all regulatory guidelines
* Liaising with the Quality Department for the generation of all departmental quality documents
* Generating GMP-compliant SOPs, protocols, and reports
* Generating risk assessments for laboratory and test items as required
* Maintaining Laboratory Data Integrity and compliance
About Biologics Testing Solutions
With over 50 years of experience and proven regulatory expertise, our Biologics group addresses challenging projects for biotechnology and pharmaceutical companies worldwide. We offer various services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies, stability, and lot release programs. We support clients throughout the biologic development cycle from establishing and characterizing cell banks through preclinical and clinical studies to marketed products.
About Charles River
We are an early-stage contract research organization. We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services. These services support clients from target identification through preclinical development. We also provide a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities.
With over 20,000 employees within 110 facilities in over 20 countries, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients' unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies, and hospitals and academic institutions around the world.
We are passionate about our role in improving the quality of people's lives. Our mission, excellent science, and strong sense of purpose guide us in all that we do. 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.
We recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.