Charles River Laboratories
Senior Associate Scientist, Method Developer
Charles River Laboratories, Mattawan, Michigan, United States, 49071
Senior Associate Scientist, Method Developer
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Senior Associate Scientist, Method Developer
role at
Charles River Laboratories
Job Summary: Immunotox personnel are responsible for the development, performance, and support of flow cytometry, ELISpot, and other immunological cell-based assays. Duties include but are not limited to: assisting in sample analysis for both internal studies as well as external client-based studies in a GLP compliant environment; aseptic cell culture techniques; sample preparation, cellular staining, and sample analysis for flow cytometry; development and optimization of flow cytometry and ELISpot assays.
Essential Functions
Effectively manage a portfolio of sample analysis projects while ensuring timelines are met in a single operational area with oversight.
Execute review and approval of data with 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 oversight.
Assist with oversight the completion of laboratory investigations, assay troubleshooting and quality observations.
Assist in problem solving for technical and/or regulatory issues with oversight.
Responsible for writing and preparing study plans/protocols/amendments with minimal oversight.
Participate in Sponsor visits/tours with minimal oversight.
Develop expertise in developing and validating quantitative/qualitative methods/procedures with limited complexity/scope in one operational area with minimal oversight.
Perform data analysis using appropriate software with minimal oversight.
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.
Function as a liaison, maintaining timely and frequent communication between CRL and Sponsor/Client/SD with minimal oversight.
Ensure scientific integrity of studies with minimal oversight.
Function as a Principal Investigator, Individual Scientist and/or Study Director as assigned with minimal oversight.
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 oversight.
Develop knowledge 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 oversight.
Performs all other related duties as assigned.
Job Qualifications
Bachelor's degree (BA/BS) with 5-7 years of relevant experience, Master's degree (MS) with 1-2 years of relevant experience, Doctorate (PhD) with no experience; equivalent combinations may be accepted.
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.
Ability to work extended hours beyond normal schedule as needed.
Ability to work under specific time constraints.
The pay for this position is $80K/year.
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 IND enabling studies to tailored packages and total laboratory support, our team designs and executes programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Approximately 300 IND programs are conducted annually in our Safety Assessment facilities.
About Charles River Charles River is an early-stage contract research organization (CRO) delivering GLP and non-GLP discovery and safety assessment services. We provide a wide portfolio of products and services to support clients from target identification through preclinical development, including clinical laboratory testing needs and manufacturing activities. With over 20,000 employees across 110 facilities in 20+ countries, we coordinate worldwide resources to resolve client challenges.
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 require accommodation due to a disability to complete any forms or participate in the resume submission process, please contact a member of our Human Resources team by emailing crrecruitment_US@crl.com.
For more information, please visit www.criver.com.
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Senior Associate Scientist, Method Developer
role at
Charles River Laboratories
Job Summary: Immunotox personnel are responsible for the development, performance, and support of flow cytometry, ELISpot, and other immunological cell-based assays. Duties include but are not limited to: assisting in sample analysis for both internal studies as well as external client-based studies in a GLP compliant environment; aseptic cell culture techniques; sample preparation, cellular staining, and sample analysis for flow cytometry; development and optimization of flow cytometry and ELISpot assays.
Essential Functions
Effectively manage a portfolio of sample analysis projects while ensuring timelines are met in a single operational area with oversight.
Execute review and approval of data with 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 oversight.
Assist with oversight the completion of laboratory investigations, assay troubleshooting and quality observations.
Assist in problem solving for technical and/or regulatory issues with oversight.
Responsible for writing and preparing study plans/protocols/amendments with minimal oversight.
Participate in Sponsor visits/tours with minimal oversight.
Develop expertise in developing and validating quantitative/qualitative methods/procedures with limited complexity/scope in one operational area with minimal oversight.
Perform data analysis using appropriate software with minimal oversight.
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.
Function as a liaison, maintaining timely and frequent communication between CRL and Sponsor/Client/SD with minimal oversight.
Ensure scientific integrity of studies with minimal oversight.
Function as a Principal Investigator, Individual Scientist and/or Study Director as assigned with minimal oversight.
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 oversight.
Develop knowledge 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 oversight.
Performs all other related duties as assigned.
Job Qualifications
Bachelor's degree (BA/BS) with 5-7 years of relevant experience, Master's degree (MS) with 1-2 years of relevant experience, Doctorate (PhD) with no experience; equivalent combinations may be accepted.
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.
Ability to work extended hours beyond normal schedule as needed.
Ability to work under specific time constraints.
The pay for this position is $80K/year.
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 IND enabling studies to tailored packages and total laboratory support, our team designs and executes programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Approximately 300 IND programs are conducted annually in our Safety Assessment facilities.
About Charles River Charles River is an early-stage contract research organization (CRO) delivering GLP and non-GLP discovery and safety assessment services. We provide a wide portfolio of products and services to support clients from target identification through preclinical development, including clinical laboratory testing needs and manufacturing activities. With over 20,000 employees across 110 facilities in 20+ countries, we coordinate worldwide resources to resolve client challenges.
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 require accommodation due to a disability to complete any forms or participate in the resume submission process, please contact a member of our Human Resources team by emailing crrecruitment_US@crl.com.
For more information, please visit www.criver.com.
#J-18808-Ljbffr