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 Overview
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 Immunogenicity 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 sample analysis in both the regulated and non-regulated space of non-clinical and clinical studies.
Essential Functions (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
Efficiently perform supervisory responsibilities in accordance with organizational policies and applicable laws to include interviewing, hiring, training and developing employees
Develop organizational strength by hiring, identifying and developing personnel who are scientifically and/or technically strong
Establish culture and atmosphere to maintain good retention and low turnover using available tools and metrics
Assist with providing costing estimates for components of applicable studies
Provide short- and long-term solutions that support continuous improvement
Maintain critical thinking, troubleshooting and time management skills aligned with needs of operational areas
Demonstrate effective communication skills through informal discussions with peers, supervisor, team, cross-site, and externally with collaborators and sponsors
Ensure laboratory tasks and operations are executed in compliance with SOPs, protocols, regulatory requirements as needed
Review and approve Standard Operating Procedures (SOPs), protocols, policies, best practices and study procedures
Maintain contemporaneous knowledge of regulatory requirements
Effectively plan, assign and direct work within one operational area with expanded scope and/or complexity
Establish and monitor performance metrics for operational area
Skillfully oversee the design, conduct, interpretation and reporting of studies
Effectively utilize project management systems
Lead implementation of new procedures and refinement of existing procedures to meet current and future business needs
Align operational resources with the current needs in one operational area
Manage cross-service line interdependencies in collaboration with organizational leadership
Collaborate with multiple departments within site
Lead planning (resource management, budgets and study coordination) as well as track budgets and spend vs. revenue for one operational area
Collaborate and consult with prospective Sponsors, providing scientific expertise and developing ongoing Sponsor relationships
Provide leadership, expert consultation and mentorship to cross-functional company teams
Performs all other related duties as assigned
Position is 100% on site in Mattawan, MI
Job Requirements
Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
Bachelor's degree in a scientific field with 11-14 years of relevant experience.
5-7 years of management experience required
CRO experience preferred.
Bioanalysis experience preferred.
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
Physical Demands:
While performing the duties of this job, the employee must be able to perform general office and/or laboratory procedures, which require, talking, hearing, standing, or sitting for long periods of time, typing/entering data into a computer, using appropriate instruments, reaching with hands and arms, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
Must be authorized to work in the United States without a sponsor visa, now or in the future.
The pay range for this position is $135-150k/year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location
Work Environment:
General office working conditions, the noise level in the work environment is usually quiet.
While performing the duties of this job the employee may occasionally be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots), work near toxic or caustic chemicals, work with biohazards, and/or work with live animals with risk of exposure to allergens and/or zoonotic diseases.
The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions.
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 300 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 s
