Req ID #: 229577
Mattawan, MI, US
1st
Full time
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

The Immunology and Immunochemistry disciplines support large molecule drug development using ligand binding assays (LBA), such as enzyme-linked immunosorbent assay (ELISA), to measure large molecules and their immune responses. The main types of assays include Pharmacokinetic (PK) assays to measure drug and Immunolgenicity assay to measure anti-drug antibodies (ADA) and neutralizing antibodies (NAb). Other assay types also performed are branched DNA (bDNA) and cell-based assays. An array of platforms are used to support these assays that include spectrophotometer, Meso Scale Discovery (MSD), Luminex and Gyrolab. Utilizing these platforms/assays, the teams are responsible for the method development, validation and routine samples analysis in both the regulated and non-regulated space of non-clinical and clinical studies.

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
• Performs all other related duties as assigned

JOB QUALIFICATIONS

• Minimum of a Bachelor’s degree (BA/BS) or 2 years lab / medical 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 systemsAbility 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 constraintsThe pay for this position is $23.50/hour.
  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.

• 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
• Performs all other related duties as assigne