IMPORTANT: In order to be considered for this position, a resume/RESUME must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
Job Summary
We are seeking an experienced Research Analyst for our Safety Assessment site located in Mattawan, MI.
Bioanalytical Chemistry supports the evaluations of test compounds by providing bioanalytical quantitative analysis of drug in body fluids and tissues from non-regulated and regulated studies including preclinical safety evaluations, pharmacokinetic/pharmacodynamic studies, and clinical trials. Staff participate in the development and validation of quantitative LC/MS/MS methodology, sample analysis, and interpretation and reporting of data utilizing validated hardware and software systems. This includes the development of sample extraction techniques, rapid LC separations, and employment of laboratory robotics to enhance delivery time of bioanalytical data. Staff are also knowledgeable in the application of GxP’s and applicable SOPs, along with adhering to study protocols to accurately document methods, procedures, and results for inclusion into study reports and regulatory documents.
Essential Functions:
Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
Assist with laboratory maintenance functions
Independently perform laboratory support functions such as labeling and solution preparations
Assist with maintaining study specific inventory of consumables with oversight
Write both study and non-study deviations with minimal oversight
Actively participate in process improvement initiatives with oversight
Develop critical thinking, troubleshooting and time management skills aligned with needs of the operational area
Assist in execution of routine sample analysis studies with oversight
Assist in execution of method validation projects with oversight as needed
Operate laboratory instruments with complete oversight
Assist with data analysis in appropriate software for at least one analytical platform
Job Qualifications
Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
Minimum of a Bachelor’s degree (BA/BS) or equivalent experience. No previous 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
Ability to communicate verbally and in writing at all levels inside and outside the organization.
Basic familiarity with Microsoft Office Suite
Computer skills, commensurate with Essential Functions, including the ability to learn a validated system
Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice
Ability to work under specific time constraints
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/RESUME.
Vaccine Mandate
Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19. Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition ((url removed)) so that information can be provided about the accommodation process at Charles River.
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.
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