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This is your moment

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This is your moment

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This is your moment

This is your
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This is your moment

This is your
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This is your moment

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This is your moment

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Research Scientist I – Bioanalytical Method Development

  • Req ID #: 226589_en_US
  • Mattawan, MI, US
  • 1st
  • Full time

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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 seeking a Research Scientist I for or our Method Development Bioanalytical Team site located in Mattawan, MI.

This position 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.

 

  The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:

 

• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)

• Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data

• Assist with the completion of laboratory investigations, assay troubleshooting, quality observations, and problem solving of technical and/or regulatory issues with minimal oversight

• Effectively develop and validate quantitative/qualitative methods/procedures with increased complexity/scope in one operational area with minimal oversight

• Independently perform data analysis in appropriate software for a majority of analytical platforms within an operational area

• Independently operate laboratory instruments including their respective software applications for 1- 2 analytical platforms within an operational platform

• 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

• Able to recognize method and/or data issues and communicate them to management to minimize study impact independently

• Independently prepare summary of method development data

• Write both study and non-study deviations with minimal oversight

• Full understanding of regulatory and GXP requirements, industry standards and company SOPs within one operational area

• Independently lead the lab staff in the completion of method validation studies

• Provide support to staff members as required by operational area as needed

• Actively participate in internal process improvements, presentations and harmonization efforts

• Performs all other related duties as assigned

    Job Qualifications

     

      Knowledge, Experience, Skills and Abilities required to accomplish the essential functions include but are not limited to:

     

    • Bachelor’s degree (BA/BS) with 7-9 years of relevant working experience. Master’s 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
    • LC/MS/MS experience required
    • Large Molecule experience preferred
    • 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
    • Ability to lift up to 30 pounds without assistance.
    • Work environmental factors included, but not limited to: everchanging temperatures, visibility to subject study animals, and standing for 8 + hours per day)
    • 0% travel
    • This is an onsite position (no remote options)

     

    The pay for this position is $80k/year.

    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 Mandate
    Charles 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 ([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.

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    Helping you find your moment

    You take great care and effort when you apply for a job with us. Rest assured that we’ll be just as diligent in finding the role that’s right for you. Here’s how our hiring process works:

    Job Search

    Learn about CRL, our culture, and why we do the work we do while also searching for roles that match your interests and expertise.

    Application

    Create a profile and apply to as many roles as you have an interest.

    Note: Depending on the role, you may be required to include a resume in your application.

    Assessment and application review

    Complete assessments, if requested, to determine whether the role is likely to be a good fit for you – and vice versa. The recruiter will review your resume and qualifications against the requirements of the role and will determine next steps.

    Note: At any point in the process, you can log into your profile to review the status of your application.

    Interview

    Engage in our inclusive interview process by meeting with a diverse group of interviewers who will provide information on the company, culture, and your role while also asking you questions to assess your skills, interests, and expertise. This is also a great time for you to ask questions.

    Note: Charles River leverages technical and behavioral-based interview questions based on our DNA (Care, Lead, Own, and Collaborate). Please familiarize yourself with the DNA and be prepared to relate your experiences to them.

    Job offer and onboarding

    Receive a competitive offer either by phone or email from a Charles River recruiter or hiring manager. The offer will include your title, salary, location, and other relevant information.

    Note: Upon acceptance, you will work with your recruiter to confirm a start date and will receive paperwork to electronically complete prior to your start. For US-based roles, upon your acceptance, you will be required to take a pre-employment drug screen and pass a criminal background check.

    Job Search

    Learn about CRL, our culture, and why we do the work we do while also searching for roles that match your interests and expertise.

    Application

    Create a profile and apply to as many roles as you have an interest. Note: Depending on the role, you may be required to include a resume in your application.

    Assessment and Application Review

    Complete assessments, if requested, to determine whether the role is likely to be a good fit for you – and vice versa. The recruiter will review your resume and qualifications against the requirements of the role and will determine next steps.
    Note: At any point in the process, you can log into your profile to review the status of your application.

    Interview

    Engage in our inclusive interview process by meeting with a diverse group of interviewers who will provide information on the company, culture, and your role while also asking you questions to assess your skills, interests, and expertise. This is also a great time for you to ask questions. Note: Charles River leverages technical and behavioral-based interview questions based on our DNA (Care, Lead, Own, and Collaborate). Please familiarize yourself with the DNA and be prepared to relate your experiences to them.

    Job offer and onboarding

    Receive a competitive offer either by phone or email from a Charles River recruiter or hiring manager. The offer will include your title, salary, location, and other relevant information. Note: Upon acceptance, you will work with your recruiter to confirm a start date and will receive paperwork to electronically complete prior to your start. For US-based roles, upon your acceptance, you will be required to take a pre-employment drug screen and pass a criminal background check.

    Important things are happening every moment at Charles River. This means exciting new career opportunities for you to explore. Take a look and apply today!

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    About Charles River

    Charles River is an early-stage Contract Research Organization (CRO). Here, we are passionate about our role in improving the quality of people’s lives. With 100 sites 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, hospitals, and academic institutions around the world.

    Charles River laboratory professional at a lab bench in a state-of-the-art laboratory environment looking through a microscope.

    Supporting your well-being

    Your dedication and passion make a life-saving difference in lives around the world. We’re committed to providing you with benefits that elevate your quality of life.

    Financial

    • Earnings + incentives
    • Retirement benefits
    • Vacation + time away
    • Recognition
    • Employee assistance fund

    Career

    • Professional development opportunities
    • Career development
    • Awards
    • Educational support

    Health and wellness coverage

    • Employee well-being support
    • Family support programs
    • Parental benefits + family formation benefits
    • Work-life balance flexibility

    Social and Community

    • Culture of inclusion
    • 11 employee resource groups (ERGs) with >3,000 members
    • Opportunities for paid volunteer time off
    • Community outreach + matching gift + engagement activities

    Financial

    • Earnings + incentives
    • Retirement benefits
    • Vacation + time away
    • Recognition
    • Employee assistance fund

    Career

    • Professional development opportunities
    • Career development
    • Awards
    • Educational support

    Health and wellness coverage

    • Employee well-being support
    • Family support programs
    • Parental benefits + family formation benefits
    • Work-life balance flexibility

    Social and Community

    • Culture of inclusion
    • 11 employee resource groups (ERGs) with >3,000 members
    • Opportunities for paid volunteer time off
    • Community outreach + matching gift + engagement activities
    Charles River laboratory professional at a lab bench in a state-of-the-art laboratory environment looking through a microscope.

    About Charles River

    Charles River is an early-stage Contract Research Organization (CRO). Here, we are passionate about our role in improving the quality of people’s lives. With 100 sites 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, hospitals, and academic institutions around the world.