Research Scientist I

Charles River; Michigan; On-site; USD 105,000 - 115,000; Full time

Job summary

The Molecular Imaging discipline at Charles River supports small and large molecule drug development through translational imaging platforms (PET, SPECT, CT, MRI) and radiopharmaceutical production for in vivo/ex vivo studies.

Essential Functions include performing procedures per protocols, collaborating across teams to meet timelines, troubleshooting regulatory issues, and maintaining data quality within one area of focus.

Qualifications

• Bachelor’s degree with 7-9 years of relevant working experience; Master’s with 3-4 years; Doctorate with 1-2 years.
• Ability to communicate verbally and in writing at all levels inside and outside the organization.
• Basic familiarity with Microsoft Office Suite; ability to learn a validated system.

Responsibilities

• Efficiently perform and document all procedures, materials, and results in compliance with applicable regulatory standards.
• Actively communicate and collaborate across operational areas to meet timelines and produce quality data.
• Assist in problem solving for technical and/or regulatory issues with minimal oversight.
• Independently operate laboratory instruments for 1-2 platforms within one functional area.
• Write study and non-study deviations with minimal oversight.

Skills

Regulatory compliance

Communication skills

Team collaboration

Problem solving

Laboratory data analysis

Education

Bachelor’s degree BA/BS with 7-9 years experience

Master’s degree MS with 3-4 years experience

Doctorate PhD with 1-2 years experience

Tools

Microsoft Office Suite

Validated systems

Job description

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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, we’ll help you build a career that you can feel passionate about.

Summary

The Molecular Imaging discipline supports small and large molecule drug development through the application of translational, nuclear imaging, quantitative autoradiography and radiopharmaceutical production. Primary translational, nuclear imaging platforms and other applicable imaging platforms consist of Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) platforms. Primary radiopharmaceutical production efforts are focused on development of novel and industry standard automated and manual radiolabeling and production methods to enable in vivo and ex vivo imaging to assess differing parameters of small and large molecules using applicable radioisotopes, such as: 11C, 18F, 64Cu, 68Ga, 89Zr, 99mTc, 111In, 123I, 124I, 125I, 131I, 177Lu, 203Pb, etc. Utilizing these platforms/assays, the team is for execution of preclinical studies in small and large animal models in both regulated and non-regulated preclinical studies.

Essential Functions: 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 in problem solving for technical and/or regulatory issues with minimal oversight
• Assist the completion of laboratory investigations, assay troubleshooting and quality observations with minimal oversight
• 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 operate laboratory instruments including their respective software applications for 1-2 platforms within one functional area
• Develop critical thinking, troubleshooting and time management skills aligned with needs of the operational area
• Independently follow batch records to execute established automated synthesis / module cleaning / QC Assays / metabolite profiling / protein binding assays, etc.
• Independently perform data analysis in appropriate software
• Write both study and non-study deviations with minimal oversight
• Full understanding of regulatory and GXP requirements, industry standards and company SOPs within one functional area
• Provide support to staff members as required by operational area as needed
• Participate with internal process improvements, presentations, and harmonization efforts
• Performs all other related duties as assigned

Job Requirements

• 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
• 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
• Must be authorized to work in the United States without a sponsor visa.

The pay for this position is $105-115k/year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location

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 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles RiverCharles 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 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 [e-mail]. 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: KalamazooJob Segment: Research Scientist, Testing, Pharmaceutical, Data Analyst, Science, Technology, Research, Data