Research Scientist I - Project Scientist - Bioanalytical Chemistry 1
Company: Charles River
Location: Mattawan
Posted on: August 6, 2022
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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 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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