Job OverviewThe Immunotox group supports drug development by investigating immune responses using flow cytometry. The group supports immunophenotyping endpoints, isolation of PBMCs and cell-based stimulation assays. Utilizing these platforms/assays, the team is responsible for the method development, validation and routine sample analysis in both the regulated and non-regulated space of non-clinical studies.
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 RequirementsQualifications: - 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 (PhD) with 1-2 years of relevant working experience.
- Flow cytometry experience required.
- 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, now or in the future.
The pay rate for this role is $95k/year.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.
