QC Raw Materials Supervisor
Memphis, TN, US, 38118 Memphis, TN, US, 38118
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 Supervisor QC Raw Materials will serve as the subject matter expert and leader of a multifaceted team ensuring sample management, controlled testing, and technical review are performed in a flawless and timely fashion. The individual will need a strong understanding of flow cytometry, general bioassays, and the logistics of sample management all performed within compliance of the various guidance and regulatory groups that oversee pharmaceutical production. A strong candidate should show leadership through training, mentoring, and a confidence founded by knowing the regulations and a strong knowledge of science. The ability to work effectively and autonomously as part of a multi-disciplinary team as a strong motivator to achieve company goals is a must for candidates seeking this position. A strong desire to learn and teach less experienced staff needs to be a defining characteristic for this position. This individual will be a group leader, responsible for oversight of junior and mid-level staff.
- Compliance and understanding of cGMP/ GLP regulations as well as excellent documentation skills in order to complete paperwork
- Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies.
- Significant flow cytometry experience
- Significant cell-based, in vitro assays
- Significant understanding of sample management in a controlled environment
- Group leader for assigned controlled testing and may consist of flow cytometry, cell-based, in vitro assays assigned to junior and mid-level staff to ensure the Quality of the drug product
- Some knowledge and technical expertise in areas of assay development, optimization and validation leveraging off the-shelf technologies in combination with novel ideas would be valuable
- Understanding of immunology and the current field of immunotherapies
- Study design, data/ statistical analysis (e.g. use of SigmaPlot, JMP and Excel), reporting results in both written and oral format (presentation)
- Familiarity with basic core QC areas including product/material stability, trending, comparability, qualification/ validation, compendia methods, etc.
Job Qualifications
- Bachelor’s in a science related field preferred
- 2+ years of cGMP experience in a quality control biotechnology/pharmaceutical environment
- Experience working with cell and/or gene therapy products
Compensation Data
The pay range for this position is $74,700 to $85,500. Please note that salaries vary within the range based on factors but not limited to experience, skills, education and location.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
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, or 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 [email protected]. 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: Memphis
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