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Research Scientist- Safety Assessment

Charles River Laboratories International Inc (CRL)

Mattawan, MI, US, 49071

Research Scientist- Safety Assessment Req ID #:  204716 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, we’ll help you build a career that you can feel passionate about. Job Summary We are seeking a Research Scientist- Safety Assessment for our Study Directors- DSE at our Mattawan, MI location.

A Research Scientist - Safety Assessment serving as a study director (SD) is responsible for overseeing study conduct of preclinical efficacy and/or toxicology studies assigned by test facility management (TFM) within safety assessment; overseeing protocols/study plans; coordinating with technical teams for execution of studies, including establishing study schedules, verifying that standard operating procedures (SOPs) are available and adhered to, overseeing data recording and reporting, and verifying that regulatory requirements/expectations are met. The individual in this role interprets preclinical toxicity studies, evaluates and prepares reports from the data collected during these studies, communicates with sponsor representatives, and initiates contact with potential clients. May be involved with development of new technologies/procedures and may be required to manage departmental and procedural projects.

 

Essential Functions (The fundamental Duties & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed: Function as an independent SD, working on studies/programs of moderate to difficult complexity. See detailed role and responsibilities of Study Director below: Design, write, review and edit study plans/protocols, amendments and study schedules that define and schedule all study activities. Oversee and coordinate study procedures. Verify that projects are performed according to SOPs and good laboratory practices (GLP) regulations. Write, review and edit draft or final reports that document all study related procedures and results. Communicate with sponsors on study related business. Job Qualifications

Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to: Bachelor’s/ Master’s /PhD/PharmD/DVM/MD degree or equivalent in Toxicology, Pharmacology or a related discipline; with 5 or more years of related industry experience. Meets expectations related to essential duties and responsibilities of Research Scientist 1. May represent an entry level for individual with relevant PharmD/DVM/MD degree or equivalent in Toxicology, Pharmacology or a related discipline An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Success in this role requires familiarity with: study/project costs and impact of changes, local and international regulations and GLPs as they relate to primary area of focus, study process from proposal to report, quality assurance (QA)/quality control (QC) processes, IACUC process, the SD role in animal welfare, effective communication with veterinary staff and internal/external clients in a manner that generates confidence and builds trust, and communication with technical supervisor and Scientific Manager on issues of overall project costs and its importance related to staffing and equipment issues. Demonstrated ability to anticipate and recognize potential problems within programs and effectively communicate alternatives to clients and a meaningful fashion. Strong communications skills, 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. 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.

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 (crrecruitment_US@crl.com) 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 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 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 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.

 

For more information, please visit www.criver.com.

Nearest Major Market: Kalamazoo

Job Segment: Research Scientist, Pharmaceutical, Quality Assurance, Recruiting, Science, Research, Technology, Human Resources

Job posted: 2022-11-16

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