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Research Scientist I - Project Scientist - Bioanalytical Chemistry 1

Company: Charles River
Location: Mattawan
Posted on: August 6, 2022

Job Description:

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.IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.Job Summary 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 (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed: --- Effectively manage a portfolio of sample analysis projects while ensuring timelines are met in a single operational area with oversight--- Execute review and approval of data with oversight for final scientific/technical decisions within a single operational area--- Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software with oversight--- Assist with oversight the completion of laboratory investigations, assay troubleshooting and quality observations--- Assist in problem solving for technical and/or regulatory issues with oversight--- Responsible for writing and preparing study plans/protocols/amendments with minimal oversight--- Participate in Sponsor visits/tours with minimal oversight--- Develop expertise in developing and validating quantitative/qualitative methods/procedures with limited complexity/scope in one operational area with minimal oversight--- Perform data analysis using appropriate software with minimal oversight--- Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas--- Demonstrate effective communication skills through informal discussions with peers, supervisor, and team--- Function as a liaison, maintaining timely and frequent communication between CRL and Sponsor/Client/SD with minimal oversight --- Ensure scientific integrity of studies with minimal oversight--- Function as a Principal Investigator, Individual Scientist and/or Study Director as assigned with minimal oversight--- Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data--- Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)--- Write, review and approve deviations with oversight--- Develop knowledge of regulatory and GXP requirements, industry standards and company SOPs within one operational area--- Effectively manage a small portfolio of research projects including method development and validation while ensuring timelines are met in a single operational area with oversight--- Performs all other related duties as assignedJob QualificationsQualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to: Experience in a contract research organization Bachelor's degree (BA/BS) with 7-9 years of relevant working experience. Master's degree (MS) with 3-4 years of relevant work experience. Doctorate degree (PhD) with 1-2 years of relevant working experience 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/CV. Vaccine MandateCharles 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 (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River. About Safety AssessmentCharles 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.

Keywords: Charles River, Kalamazoo , Research Scientist I - Project Scientist - Bioanalytical Chemistry 1, Other , Mattawan, Michigan

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