Qureos Mentor

Charles River Laboratories

<div><p>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&rsquo;ll help you build a career that you can feel passionate about.</p><div><div><div><h2 class="jobSectionHeader"><b>
Job Summary</b></h2>
</div><div><p>
We are seeking a<b> Supervisor</b> for our Bioanalytical Chemistry team at our Safety Assessment Site located in <b>Cleveland, OH</b>.
</p><p></p><p><b>Discipline Summary:</b><br>
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 GxP&rsquo;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.</p><p><b><br>
Essential Functions</b><i> (The fundamental Competencies/Skills &amp; Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
</i></p><ul><li>Efficiently perform supervisory responsibilities in accordance with organizational policies and applicable laws to include interviewing, hiring, training and developing employees</li><li>
Develop organizational strength by hiring, identifying and developing personnel who are scientifically and/or technically strong</li><li>
Establish culture and atmosphere to maintain good retention and low turnover using available tools and metrics</li><li>
Assist with providing costing estimates for components of applicable studies</li><li>
Provide short- and long-term solutions that support continuous improvement</li><li>
Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas</li><li>
Demonstrate effective communication skills through informal discussions with peers, supervisor, and team</li><li>
Ensure laboratory tasks and operations are executed in compliance with SOPs, protocols, regulatory requirements</li><li>
Establish and review Standard Operating Procedures (SOPs), protocols, policies, best practices and study procedures</li><li>
Develop contemporaneous knowledge of regulatory requirements</li><li>
Effectively plan, assign and direct work within one operational area</li><li>
Performs all other related duties as assigned</li></ul><p>
</p><p><b>The pay range for this position is $72-75K. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location</b></p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Qualifications</b></h2>
</div><div><p><i>
(Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:</i></p><ul><li>
Bachelor&rsquo;s degree or equivalent with 5-7 years of relevant experience. No previous management experience required</li><li>
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above</li><li>
Ability to communicate verbally and in writing at all levels inside and outside the organization</li><li>
Basic familiarity with Microsoft Office Suite</li><li>
Computer skills, commensurate with Essential Functions, including the ability to learn a validated system</li><li>
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</li><li>
Ability to work under specific time constraints</li></ul></div></div></div><p><b>
About Safety Assessment</b><br>
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.</p><p></p><p><b><br>
About Charles River</b><br>
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&rsquo; 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.</p><p></p><p><br>
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&rsquo;s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.</p><p></p><p><br>
At Charles River, we are passionate about our role in improving the quality of people&rsquo;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.</p><p></p><p><b><br>
Equal Employment Opportunity</b></p><p>
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.</p><p></p><p><br>
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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.</p><p></p><p><br>
For more information, please visit www.criver.com.</p><div>
226461</div></div>

Job Id: 42uA9PPNYtM2vPHfsZgDmOoU5TDAWzBgOBNPardHFxhl+28YIWVME4Bj05m5eAa8Rl2puFZC+oIZPD0kylmEL0N2iNi5n4SdGDLEAHbLtsBgSrgr

Supervisor- Bioanalytical Chemistry 1

<div><p>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&rsquo;ll help you build a career that you can feel passionate about.</p><div><div><div><h2 class="jobSectionHeader"><b>
Job Summary</b></h2>
</div><div><p>
The Immunology and Immunochemistry disciplines support large molecule drug development using ligand binding assays, such as enzyme-linked immunosorbent assay, to measure large molecules and their immune responses. The main types of assays include Pharmacokinetic assays to measure drug and Immunogenicity assay to measure anti-drug antibodies and neutralizing antibodies. Other assay types also performed are branched DNA and cell-based assays. An array of platforms are used to support these assays that include spectrophotometer, Meso Scale Discovery, Luminex and Gyrolab. Utilizing these platforms/assays, the teams are responsible for the method development, validation and routine sample analysis in both the regulated and non-regulated space of non-clinical and clinical studies.</p><p>
</p><p><b>Essential Functions:</b></p><ul><li>
Effectively manage a portfolio of sample analysis projects while ensuring timelines are met in a single operational area with oversight</li><li>
Execute review and approval of data with oversight for final scientific/technical decisions within a single operational area</li><li>
Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software with oversight</li><li>
Assist with oversight the completion of laboratory investigations, assay troubleshooting and quality observations</li><li>
Assist in problem solving for technical and/or regulatory issues with oversight</li><li>
Responsible for writing and preparing study plans/protocols/amendments with minimal oversight</li><li>
Participate in Sponsor visits/tours with minimal oversight</li><li>
Develop expertise in developing and validating quantitative/qualitative methods/procedures with limited complexity/scope in one operational area with minimal oversight</li><li>
Perform data analysis using appropriate software with minimal oversight</li><li>
Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas</li><li>
Demonstrate effective communication skills through informal discussions with peers, supervisor, and team</li><li>
Function as a liaison, maintaining timely and frequent communication between CRL and Sponsor/Client/SD with minimal oversight</li><li>
Ensure scientific integrity of studies with minimal oversight</li><li>
Function as a Principal Investigator, Individual Scientist and/or Study Director as assigned with minimal oversight</li><li>
Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data</li><li>
Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)</li><li>
Write, review and approve deviations with oversight; Develop knowledge of regulatory and GXP requirements, industry standards and company SOPs within one operational area</li><li>
Effectively manage a small portfolio of research projects including method development and validation while ensuring timelines are met in a single operational area with oversight</li><li>
Performs all other related duties as assigned</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Qualifications</b></h2>
</div><div><ul><li>Bachelor's degree (BA/BS) with 5-7 years of relevant working experience. Master's degree (MS) with 1-2 years of relevant work experience. Doctorate degree (PhD) with no experience</li><li>
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above</li><li>
Ability to communicate verbally and in writing at all levels inside and outside the organization</li><li>
Basic familiarity with Microsoft Office Suite; Computer skills, commensurate with Essential Functions, including the ability to learn a validated system</li><li>
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</li><li>
Ability to work under specific time constraints</li></ul><p>
</p><p><b><i>The pay for this position is $78k/year.</i></b></p></div></div></div><p><b>
About Safety Assessment</b><br>
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.</p><p><b><br>
About Charles River</b><br>
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&rsquo; 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.</p><p>
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&rsquo;s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.</p><p>
At Charles River, we are passionate about our role in improving the quality of people&rsquo;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.</p><p>
We&rsquo;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.</p><p></p><p><b><br>
Equal Employment Opportunity</b></p><p>
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.</p><p>
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.</p><p>
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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.</p><p></p><p><br>
For more information, please visit www.criver.com.</p><div>
226586</div></div>

Job Id: +SfgSh+7A4YTCn4egR8QGv4g5rOgQu1Rp1sm962/vbENcbVjbae2rv+5RdFF0UKaUuXgzSknD2B0N4FRCAQTwNayPiM3UWtPYLz+AdzhI31BB/i8

Senior Associate Scientist, Project Scientist - Large Molecule Bioanalysis

<div><p>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&rsquo;ll help you build a career that you can feel passionate about.</p><div><div><div><h2 class="jobSectionHeader"><b>
Job Summary</b></h2>
</div><div><p>
This leadership role is responsible for a team of Quality Operations Specialists, which will require providing oversight of quality documentation and operations in adherence to cGMPs and SOP regulations. QOps Supervisors will represent Quality at cross-functional meetings, providing Quality input and decision making in Quality events and deviations. They will provide training to groups and departments when needed.
</p><p></p><div><b>ESSENTIAL DUTIES AND RESPONSIBILITIES:
</b><br>
<ul><li>Assume supervisory responsibility for a team of Quality Operations (QOps) Specialists, including scheduling, work assignment, and productivity monitoring</li><li>Coordinate review of manufacturing Batch Production Records (BPRs) and associated supporting documentation including logbooks, Quality Control (QC) testing reports, environmental monitoring reports, etc.</li><li>Support Internal Management System by engagement in Work Center Team activities</li><li>Serve as owner of assigned nonconformances, CAPA, change controls, or other quality system documents and collaborate to drive completion</li><li>Create, review and approve documents in electronic document management systems</li><li>Serve as QOps representative for client project teams as assigned by management</li><li>Coordinate performance of key QOps functions by team members, including line clearances, general manufacturing support, product shipment, raw material receipt and release, etc.</li><li>Participate in departmental and cross-functional continuous improvement efforts</li><li>Train and mentor assigned QOps Specialists and Leads</li><li>Consistently set a high standard for quality of work</li><li>Promote a safety mindset through daily actions and communication with team members</li><li>Manage risk and escalate issues to QOps management in a timely manner</li><li>Communicate professionally, effectively, and efficiently with all clients, internal and external</li><li>Demonstrate flexibility when confronted with high stress/emergency situations, shifting</li><li>Perform all other duties as necessary</li></ul></div></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Qualifications</b></h2>
</div><div><ul><li>Bachelors degree in a life science or related field preferred
</li><li>Minimum of 5 year GMP related experience in biopharmaceutical/pharmaceutical or related industry or a combination of 5 years of education and related work experience required</li><li>Demonstrated leadership capability</li><li>Experience with GMP regulatory requirements</li><li>Ability to multi-task effectively</li><li>Excellent written and verbal communication skills</li><li>Ability to prioritize daily activities in order to meet client needs on time of established time lines in a fast-paced environment</li><li>Proficient in computer system use, including but not limited to Microsoft Office (Word, Excel, Power Point)</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Compensation Data</b></h2>
</div><div><p>
The pay range for this position is $83,380 to $105,200. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.</p></div></div></div><p><b>
About Biologics Testing Solutions</b><br>
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.</p><p><b>
About Charles River</b><br>
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&rsquo; 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.</p><p>
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&rsquo;s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.</p><p>
At Charles River, we are passionate about our role in improving the quality of people&rsquo;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.</p><p>
We&rsquo;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.</p><p><b>
Equal Employment Opportunity</b></p><p>
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 (including sexual orientation, gender identity, and expression), 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.</p><p>
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.</p><p>
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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.</p><p>
For more information, please visit www.criver.com.</p><div>
228090</div></div>

Job Id: vK3sjN0KnUcDZXd3TrtxZ2kJRapeGw6wswMUtIYEVz1bFaolmpWdKjSADDR2Gfq0+y3n47StcybdzSppS24QwOYlvSHOrUfSjgeBFd9nD9LAaci8

Quality Operations Supervisor

Join Charles River Laboratories and explore 3 exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.