PK Research Scientist 2 - Remote

Company: Charles River Laboratories
Location: Mattawan
Posted on: January 27, 2023

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 SummaryWe are hiring for a PK Research Scientist 2, Pharmacokinetics at our Mattawan, MI site.A PK Research Scientist 2 is responsible for providing support of studies aimed at determining the toxicokinetics (TK), toxicodynamics (TD), pharmacokinetics (PK), and pharmacodynamics (PD) of biologically active compounds or new candidate drugs in body fluids and tissues of laboratory animals and/or humans. Developing and executing protocols/plans in accordance with company Standard Operating Procedures (SOPs) and industry regulatory guidelines (GxP).Develops training materials and provides training for the kinetic analysts and supporting functional areas staff on the compliant use of kinetic software applications.Plans, designs, analyzes, interprets and reports toxicokinetic (TK)/toxicodynamic (TD) and pharmacokinetic (PK)/pharmacodynamic (PD) data for GxP and non-GLP studies.Prepares TK/TD/PK/PD components of study reports.Provides accurate and timely project status/updates to management and external customers.Reads, understands and follows SOPs, safety requirements, regulatory guidelines and company policies.Interprets and presents project-related study results to the Sponsor/management as appropriate.Demonstrates commitment to quality and animal welfare.Demonstrates a willingness to perform additional work as assigned by management and as a part of the individual's development plan.Develops, modifies and/or optimizes existing/new TK/TD/PK/PD methods, techniques or procedures.Assists with training and developing employees.Expected to work independently, participate in process improvement initiatives and may function as a Principal Investigator or Individual Scientist.Other duties as assigned.Job QualificationsPh.D. or Master's/Bachelor's degree in a related field and 7+ years of relevant experience; contract research organization experience preferred.An equivalent of education and experience may be accepted as satisfactory.Expert knowledge of GxPs and applicable industry guidance documents.Working knowledge of TK/TD/PK/PD theory.Experience with PK related software including but not limited to: Phoenix* WinNonlin* and SigmaPlot* running independent studies.Basic familiar with Microsoft Office Suite.Computer skills, commensurate with Essential Functions including ability to learn a validated system.Ability to work extended hours beyond normal work schedule to include but not limited to: evenings, weekends, extended 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 Laboratories, Kalamazoo , PK Research Scientist 2 - Remote, Other , Mattawan, Michigan