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.
We are seeking an experienced Research Scientist I for our Safety Assessment site located in Ashland, Ohio.
Researches, designs and/or undertakes chemistry activities to design, synthesis and produce drug candidate compounds for testing in drug discovery assays. Includes computer-aided drug design, medicinal chemistry optimisation of compound properties, synthesis, purification and analysis of compound and phamaceutic studies.
Primarily responsible for development and validation of new analytical methods including mass spectral methods, development of new analytical technology, including associated standard operating procedures, and training of staff in new methods and technologies. Also responsible for all aspects of analytical support on assigned projects, including interaction with the study director, sponsor monitor, or other representatives of the sponsor, maintenance and review of study records, preparation of reports, and addressing audit findings. Assists in the direction of daily laboratory operations within the Analytical Chemistry department. Functions as a senior analyst. Will serve as study director on analytical studies. Other responsibilities include scheduling of study activities, making personnel assignments, inception, review and revision of SOPs to assure compliance with GLPs, auditing of study records for GLP/protocol compliance and the writing of final summary reports. Duties also include the performance of method development and/or validation for new studies and the orientation and training of new department employees, including maintenance of the associated documentation. Assures adherence to established safety practices. Provides technical support to chemists, group supervisors, department management, study directors and clients. May function as coordinator of a technical specialty area such as instrument and/or software training, or in a nonscientific area such as quality control/efficiency, study scheduling, safety, report preparation, or standard operating procedures. Other responsibilities as specified by department management.
Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master's degree (M.S./M.A.) or Ph.D./D.V.M. preferred.
Experience: Minimum of 9 to 12 years related experience in the contract research, academic, or pharmaceutical industry.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Certification/Licensure: Certification as appropriate for specialty preferred.
Other: Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Knowledge of applicable international guidelines for all types of studies. Demonstrate leadership skills as they pertain to intra and inter-departmental initiatives, Sponsor interactions, and business development. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations.
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 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.