Job description
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.
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
Job Summary
Broad knowledge of quality control testing and working in a GMP laboratory environment. Participates in assay development qualification/validation projects. Responsible for writing and review of reports, deviations, CAPAs and OOS documents. Participates in testing using qualified/validated methods and training of junior staff. Positions requires some knowledge and experience in cell culture, ELISA, gel-electrophoresis, Western blot, PCR, and other virus-based assays.
Key Responsibilities and Duties:
• Knowledgeable in qPCR, ddPCR, and related methods, for viral based products.
- Knowledgeable in cell culture and cell-based assays for vial products (Plaque assay, TCID50 etc.)
- Experience performing ELISAs, gel-electrophoresis, Western Bot
- Experience working in a GMP lab environment.
- Experience in method development and troubleshooting as well as qualification and validation of QC methods assays.
- Attend departmental meetings and provide clients with periodic progress updates
- Demonstrated ability to analyze and interpret data
- Ability to support multiple projects concurrently
- Strong organizational, analytical, and problem-solving skills
- Effective mentoring and training of junior staff
- Conduct literature searches and design, develop, optimize and execute method development
- Author and review method development reports, SOPs, test methods, protocols, reports
- Experience writing Deviations, CAPAs and OOS documents
- Provide GMP testing support for Quality Control as needed
- Other responsibilities as needed
Job Qualifications
• BS/MS/PhD in a biological science or equivalent experience
- 8+ years of experience in a Quality Control GMP laboratory environment
- Extensive experience with assay development and qualification of methods
- Knowledge of ICH/USP and FDA guidelines
- Excellent verbal and written communication skills
- Team Player
- Demonstrates Integrity and Respect
- Delivers Results
The pay range for this position is $92,000 - $98,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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 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. 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.
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