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. Job Summary
We are seeking an Associate Director of Bioanalytical Chemistry
for our Safety Assesment site locatedAshland, Ohio.
Serve as subject matter expert to the bioanalytical department on FDA GLP regulations and guidelines as applied to LC/MS preclinical and clinical bioanalytical studies. Manage a team of bioanalytical scientists serving as Principal Investigators and Project Scientists, including providing guidance on project setup, planning, execution, and investigations that may arise. Participate in client facing discussions as a department and company representative. Support the bioanalytical department with respect to scope of work and pricing, in collaboration with Department Director and Client Services/Account Management. Provide scientific and innovative thinking with advanced level of technical skill and insight. Keep abreast of and maintain a broad knowledge of state-of-the art bioanalytical principles and theories.
The following are responsibilities related to the Associate Director role:
- Supervise and support the development of a group of Principal Investigators/Project Scientists managing bioanalytical studies
- Maintain a broad knowledge of bioanalytical principles and regulatory guidance
- Provide guidance on study conduct to assure FDA/EMA regulatory requirements and industry guidelines for bioanalytical studies are met
- Maintain oversight of project progression, assuring timely delivery and within budget
- Contribute to evaluation of results and plan follow-up investigations
- Evaluate study requirements, timelines and prices with Sponsors and other Charles River Laboratories sites
The following are minimum qualifications related to the Associate Director position:
- Education: Ph.D. in chemistry or closely related field.
- Experience: 5-10 years experience in the contract research or pharmaceutical industry conducting bioanalytical scientific research. Experience in a GLP environment required. Supervisory experience highly preferred. Extensive knowledge of LC-MS based bioanalytical sciences required.
- An equivalent combination of education and experience may be accepted as a substitute for the specific education and experience listed above.
Note: Senior Manager may be considered. Position level will be determined based on the qualifications of the candidate.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.