PK Research Scientist 2 - Remote
Company: Charles River Laboratories
Location: Mattawan
Posted on: January 27, 2023
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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
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