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Research Scientist I

Employer
Charles River Laboratories
Location
Mattawan, MI
Closing date
Feb 14, 2024

View more

Sector
Science
Organization Type
Corporate
Research Scientist I

Req ID #: 219931

Location:

Mattawan, MI, US, 49071

For 75 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, well help you build a career that you can feel passionate about.

**Job Summary**

We are seeking a **Research Scientist 1** for our **Bioanalytical Chemistry Team** in **Mattawan MI** .

**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 GxPs and applicable SOPs, along with adhering to study protocols to accurately document methods, procedures, and results for inclusion into study reports and regulatory documents.Bioanalytical Chemistry plays a crucial role in evaluating test compounds by providing accurate quantitative analysis of drugs in body fluids and tissues. Our team develops and validates cutting-edge LC/MS/MS methods, performs sample analysis, and interprets data using validated systems. We also optimize sample extraction techniques, rapid LC separations, and laboratory robotics to accelerate bioanalytical data delivery. Our expertise spans non-regulated and regulated studies, including preclinical safety evaluations, pharmacokinetic/pharmacodynamic studies, and clinical trials. GxP compliance and adherence to SOPs and study protocols ensure accurate documentation and regulatory reporting.

**Essential Functions:**

+ Manage and deliver high-quality bioanalytical projects using LC-MS/MS while ensuring timelines are met with minimal oversight

+ Review and approve of datasets using advanced software tools for bioanalytical analysis, ensuring scientific accuracy and compliance

+ Develop expertise in regulatory compliance, addressing audit observations and ensuring GXP adherence

+ Develop and validate innovative LC-MS/MS methods, expanding capabilities

+ Troubleshoot assays and investigate laboratory issues, collaborating with teams for solutions

+ Independently resolve technical and regulatory challenges, demonstrating critical thinking

+ ndependently function as a Principal Investigator, Individual Scientist and/or Study Director

+ Independently perform review of bioanalytical data analysis using appropriate software

+ Ensure compliance with regulatory standards, documenting processes, and results accurately

+ Responsible for review of study plans/protocols/amendments

+ Engage with Sponsors, hosting visits and tours, and fostering partnerships

+ Cultivate strong communication and collaboration skills, working across functions

+ Embrace leadership roles, guiding projects and mentoring team members

+ Author and review deviations, driving continuous improvement

**Job Qualifications**

+ Bachelors degree (BA/BS) with 7-9 years of relevant working experience. Masters degree (MS) with 3-4 years of relevant working 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.

+ LCMS Experience is required

+ CRO Experience preferred

+ 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.

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

**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.

**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 300 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 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients 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 peoples 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 86% of the drugs approved by the FDA in 2021.

**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.

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