Job Description
Seeking an experienced Principal Immunoassay Scientist to establish new methods, implement equipment, and ensure regulatory compliance in a Biologics Department.
Charles River Laboratories is a leading contract research organization with over 20,000 employees worldwide, providing a diverse portfolio of discovery and safety assessment services.
Job Description
For 75 years, Charles River employees have worked together to assist in the discovery, development, and safe manufacture of new drug therapies.
- Establishing new methods in the laboratory to deliver fully qualified or validated methods.
- Implementing new equipment for immune methods.
- Accountable for regulatory compliance and scientific integrity.
- Execution of complex methods in the laboratory for transfer/validation and leading troubleshooting efforts as required.
- Scheduling work in relation to method development, transfer, validation, and/or troubleshooting.
- Training and mentoring junior staff in new methods.
- Reporting of results to Project Leader, Manager, and/or Clients.
- Compliance with requirements of GMP.
Requirements
- Degree in biochemistry or immunology or other biological subject with an analytical component.
- Experience in immunoassay methods (e.g. ELISA, Western Blot, etc.).
- At least 5-10 years' experience in method development and validation of immunoassay methods.
- Good attention to details and good problems-solving skills.
- Experience in time planning.
- Excellent interpersonal and communication skills (written and verbal).
- Excellent IT skills.
- Experience of working in a GMP environment highly desirable.
About Charles River Laboratories
With over 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 characterization, bioassays, viral clearance studies, and stability and lot release programs.
Supporting clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products.
With a diverse portfolio of products and services, Charles River enables clients to create a more flexible drug development model, reducing costs, enhancing productivity, and increasing speed to market.