Research Scientist - Bioanalytical Chemistry

Position: Research Scientist I - Bioanalytical Chemistry
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.

Job Summary

BASIC SUMMARY: The incumbent will serve as a scientific team member in the conduct of preclinical and clinical research studies of basic to moderate complexity. Responsibilities include study management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Serve as a Project Scientist for the development and validation of analytical assays. This individual would be responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company standard operating procedures and industry regulatory guidelines.

This position will serve as the primary scientific contact for key clients and the on-site support of their programs.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Function independently as a Project Scientist, Principal Investigator, Individual Scientist in the direction and execution of assigned studies in compliance with regulations as they apply to the conduct of preclinical and clinical research. Provide scientific expertise in study conduct, design, and interpretation.

Review, interpret, integrate, and present data on assigned studies.

Critical review of analytical results and batch analysis as necessary.

Design, develop, and validate novel assays within the appropriate scientific discipline.

Collaborate effectively with on-site management, operations, and technical staff.

Participate in and coordinate all phases of the study planning process with appropriate departments. Develop assays, generate high-quality laboratory method, protocols, amendments, reports, and facilitate appropriate changes to study design for assigned projects and programs.

Writes and edits draft or final reports that document all study related procedures and results.

Analyze scientific problems, troubleshoot analytical methods and technical issues.

Function independently as the point of contact for the planning and execution of sponsor interaction related to assigned studies, including study planning, scheduling, conduct and reporting.

Provide prompt verbal or written communication with Sponsors on study related business.

Mentor junior staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and execution of validation studies. Review reports for peers as needed.

Attend scientific meetings, conferences and training courses to enhance job and professional skills.

Contribute to testing of new analytical technologies or introduce improvements in existing technologies.

Perform all other related duties as assigned

The pay for this position is between $100,000 and $110,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

QUALIFICATIONS:

• Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master's degree (M.S./M.A.) or PhD/DVM preferred.

Experience: Minimum of 6 years related experience in the development and/or validation of assays is preferred (i.e.: chromatographic bioanalytical)

• Other: Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Experience in a contract research organization is preferred.
• Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, Graphpad Prism, etc. and with standard laboratory calculations. Experience with Watson LIMS (preferred).

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…