For 70 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.
Charles River Horsham, our Pennsylvania location, was opened in 1979 under the name of Argus Research Laboratories and became part of Charles River in 2001. The Horsham site specializes in Reproductive and Developmental Toxicology (DART), Juvenile Toxicology, Neurobehavioral Toxicology, Phototoxicology, Gene Therapy, and Vaccine safety testing. The internationally-recognized scientists at this facility have unmatched expertise in specialty toxicology, and the facility is rapidly developing recognition for its capabilities in gene therapies for the pediatric population. Horsham is ideally located just north of historic Philadelphia, Pennsylvania and its many historic attractions, sports activities, colleges and universities, concerts and shopping. We are just a couple of hours drive to Pennsylvania’s mountains and the beaches of New Jersey, Delaware, and Maryland and, via car or Amtrak, to New York City and Washington, D.C.
This is an entry level trainee position for a Study Director/Scientist within the Safety Assessment division of Charles River Laboratories, Inc (CRL). A Study Director/Scientist has overall responsibility for the technical conduct of studies according to FDA or other applicable guidelines and Good Laboratory Practice (GLP) regulations. With guidance from senior scientific staff, serve as a Study Director in the direction and execution of assigned non-GLP and GLP studies as they apply to the conduct of preclinical research. In preparation to become a Study Director the objectives during this training period will be to ready the individual to be overall responsible of protocols/study plans, study schedules, Standard Operating Procedures and familiarity/awareness of study cost estimates. Overall interpretation of preclinical toxicity studies, evaluation and preparation of reports from the data collected during these studies, communication with sponsor representatives, initiating contact with potential clients, and may be involved with development of new technologies/procedures.
- Acquires knowledge of relevant processes and procedures established at CRL.
- Acquires knowledge and familiarity with performance expectations of a Study Director at CRL.
- Acquires knowledge of regulations and GLP’s as they relate to primary area of focus.
- Acquires knowledge of the study process from proposal to report.
- Acquires knowledge of the Quality Assurance (QA)/Quality Control (QC) process.
- Acquires knowledge of interactions with veterinary staff, the animal ethical/IACUC process, and the Study Director role in animal welfare.
- Under the supervision of Sr. Scientist(s)/Scientific Manager,
- gains understanding in designing and overseeing the accuracy of study plans/protocols and amendments that define and schedule all study activities.
- oversees and coordinates aspects of study conduct, whether performed within the department or by service departments.
- ensures that assigned projects are performed according to the Study Plan/Protocol, Standard Operating Procedures, applicable guidelines/guidance’s and/or GLP regulations.
- reviews, interprets, and analyzes preclinical data and reports (draft and final) the results of assigned studies.
- communicates (verbal or written) with internal and external clients on study-related business.
- assures that all data for assigned studies are accurately recorded and verified.
- ensures that at the end of the study, all raw data, supporting documentation, protocols, specimens and final reports are archived.
- May attend scientific meetings, conferences and training courses to enhance job and professional skills.
- Performs all other related duties as assigned.
Education: Minimum of a Bachelor’s degree (BA/BS) or equivalent in Toxicology, Pharmacology, or related discipline.
Experience: No work experience required. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.
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 ~85% of the drugs approved by the FDA in 2019.
For more information, please visit www.criver.com.
To apply, please visit https://career4.successfactors.com/sfcareer/jobreqcareer?jobId=109693&company=charlesrivP
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer - M/F/Disabled/Vet
Nearest Major Market: Philadelphia
Job Segment: Research Scientist, Scientific, Toxicology, Biotech, Science, Engineering, Research