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. 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 Gx P’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: Effectively manage a portfolio of sample analysis projects while ensuring timelines are met in a single operational area with minimal oversight Execute review and approval of data with minimal 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 minimal oversight Assist with minimal oversight the completion of laboratory investigations, assay troubleshooting and quality observations Independently assist in problem solving for technical and/or regulatory issues Responsible for review of study plans/protocols/amendments Participate in Sponsor visits/tours with minimal oversight Provide expertise in developing and validating quantitative/qualitative methods/procedures with limited complexity/scope in one operational area Independently perform data analysis using appropriate software 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 Independently function as a liaison, maintaining timely and frequent communication between CRL and Sponsor/Client/SD Independently ensure scientific integrity of studies Independently function as a Principal Investigator, Individual Scientist and/or Study Director 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 minimal oversight Full understanding 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 minimal oversight Understand the theory and application of correction factors with oversight as required by operational area Able to recognize method and/or data issues and communicate them to management to minimize study impact with minimal oversight 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 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 (Ph D) 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. 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 backssment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety backssment 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 backssment 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 backssment 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 medical 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 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, interaction, interactionual 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 xyz X@. 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.
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. Job Summary We are seeking an experienced Research Analyst for our Safety backssment site located 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 Gx P'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: Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc. ) Demonstrate effective communication skills through
informal discussions with peers, supervisor, and team Assist with laboratory maintenance functions Independently perform laboratory support functions such as labeling and solution preparations Assist with maintaining study specific inventory of consumables with oversight Write both study and non-study deviations with minimal oversight Actively participate in process improvement initiatives with oversight Develop critical thinking, troubleshooting and time management skills aligned with needs of the operational area Assist in execution of routine sample analysis studies with oversight Assist in execution of method validation projects with oversight as needed Operate laboratory instruments with complete oversight Assist with data analysis in appropriate software for at least one analytical platform Job Qualifications Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to: Minimum of a Bachelor’s degree (BA/BS) or equivalent experience.
No previous work experience required 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 The pay for this position is $23.50/hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Safety backssment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety backssment 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 backssment 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 backssment 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 medical 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 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, interaction, interactionual 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 xyz X@. 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.
