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

We are hiring for a PK Analyst I , Pharmacokinetics. This is a fully remote position aligned with our Mattawan, MI site.

A PK Analyst I 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).

• Review of draft study plans/protocols and amendments and preparation.

• To assist discussion on the design of pharmacokinetic/toxicokinetic (PK/TK) studies.

• Function as an individual Scientist (IS/PI) on PK/TK projects; perform PK/TK analysis and interpretation/reporting of results.

• Assist in the peer review of PK/TK reports.

• To assist trouble-shooting and problem-solving related to production work and scientific methodology for junior production analysis.

• Act as a scientific resource within the department for PK/TK services and collaborate with Scientists, Study Directors, Study Monitors and Sponsor representatives with regards to scientific matters associated with the conduct, interpretation and reporting of PK/TK data.

• Ensure that software used in PK/TK analysis is used according to its validation.

• To support the mentoring and training of the junior staffs.

• Assist in maintaining documentation to a satisfactory standard, satisfying the requirement of GLP, as required. This includes preparing, reviewing, updating, issuing, etc. SOPs, Guidance Documents, etc. in line with Good Laboratory Practice (GLP) and regulations published by the FDA, EPA, JMHW and OECD..

• To maintain awareness of developments in PK within the pharmaceutical industry by attending scientific meetings, symposia or workshops and publish or present results of the research whenever possible.

• As a pharmacometrician, to assist in the development and the conduct of mathematical modeling and simulations of various modeling techniques such as pharmacokinetic/pharmacodynamic models, mechanistic/disease models, adaptive designs, nonlinear mixed models, dynamic models, etc. Assist in the evaluation of new modeling and simulation tools.

• Other duties as assigned.

“ The pay range for this position is $95,000 (USD)/yr. - $105,000 (USD)/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.”

Job Qualifications

• Ph.D.,Master, Bachelor'sdegree with 1-3 years of relevant experience; Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling; contract research organization experience preferred.

• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Demonstrated knowledge of Pharmaceutical sciences, Pharmacometrics, mathematics, statistics.

• Demonstrated ability to manage multiple projects simultaneously and deliver work in a timely manner and lead scientific discussions.

• Ability to communicate verbally and in writing at all levels inside and outside the organization.

• Basic familiar 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 or extra shifts, sometimes on short notice.

• Ability to work under specific time constraints.

Competencies

Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.

Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.

Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.

Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.

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.

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition ( [email protected] ) 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.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 18,000 employees within 100 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of >80% of the drugs approved by the FDA for the past 3 years.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected] . This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

Nearest Major Market: Kalamazoo

Job Segment: Biology, Biotech, Toxicology, Pharmaceutical, Research Scientist, Science

Charles River Laboratories is a visionary leader in the development and delivery of advanced drug therapies. We provide essential products and services to pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe, to help accelerate their research and drug development efforts. At Charles River, we view every day as an opportunity to improve global health and people's lives. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.