Technician I Methods Qualification and Validation

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.

About the role

Under direct supervision, responsible for performing daily laboratory activities necessary for analytical and/or bioanalytical method testing, including reagent preparation, laboratory maintenance/monitoring, and method performance.

Responsibilities

• Perform laboratory activities necessary for molecular biology testing, including:
  • Reagent preparation (buffers, chemical solutions, complex mixtures, and media) according to standard test methods.
  • Tasks using aseptic techniques, including work within a biological safety cabinet.
• Participate in the general maintenance of all equipment related to the preparation of assay materials and the analysis of samples, and schedule repairs as required.
• Perform maintenance and/or monitoring as necessary.
• Conduct aseptic growth and manipulation of bacteria, yeast, virus, and mammalian cells.
• Make detailed observations and accurately and precisely record data, summarize data for reports, and document all activities performed in accordance with current Good Manufacturing Practice (cGMP).
• Perform a variety of molecular biology laboratory experiments, tests, and procedures, including:
  • Isolation and analysis of DNA and RNA.
  • PCR, QF-PCR, RT-QF-PCR.
  • Restriction endonuclease digestion.
  • Agarose gel electrophoresis.
  • Various blotting techniques.
  • ELISA and/or sequencing.
• Report results of experiments, tests, and procedures, and analyze data.
• Efficiently organize and plan daily activities.
• Maintain a safe working environment by adhering to company policies and procedures.
• Follow all SOPs, STMs, and cGMP/cGLP guidelines as they relate to specific tasks.
• Perform all other related duties as assigned.

Requirements

• Bachelor's degree (B.A./B.S.) or equivalent in Biology or a related discipline.
• 0-1 years of related experience in a biological lab.
• Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.
• Excellent interpersonal skills to maintain communication across biological functional groups.
• Able to communicate effectively in group or one-on-one settings.
• Basic Microsoft Office skills are a plus.

Pay

$24.70 per hour. Salaries may vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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 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. 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, and over 200 licensed 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 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 client challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies, hospitals, and academic institutions worldwide. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.