Supervisor QC Cell Culture
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
Supervisor Cell Culture will oversee the culturing of various human cell types in support of cell-based immunological product release assays. The supervisor should have a deep understanding of the culture methods utilized and oversee the performance and maintenance of procedures as specified in Standard Operation Procedures (SOPs).
- Oversee aseptic cell culture activities such as thawing, enumeration, passaging and cryopreservation of various cell line types required for QC assays
- Maintains accurate and timely records of culture manipulations and activities
- Enters culture observations and results into the appropriate trending databases for periodic analysis and trending.
- Works with QC Manager to plan work schedules in advance and assist with team management.
- Reviews test results of other QC analysts for accuracy and precision and maintains efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
- Assists the QC Team with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
- Participates in laboratory, OOS, CAPA or other investigations, as required
- May assist with technology transfer of new client assays by authoring SOPs or other required documentation and/or assisting with needed assay development work
- Perform all other related duties as assigned
Job Qualifications
- Bachelors degree in the biological sciences or related field preferred
- Minimum of 4 years relevant laboratory experience or experience in a cGMP/FDA regulated industry
- 2 years of leadership experience preferred
- Demonstrated knowledge in “core” laboratory techniques (e.g. cell culture/counting, microscopy, etc.) and aseptic techniques required
- Significant mammalian cell culture experience and understanding preferred
- Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies
- Detail-oriented with strong written and verbal communication skills
- Effective communication skills and the ability to function in a fast-paced, highly technical environment
The pay range for this position is $78,000 - $85,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, 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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Biology, Cell Biology, Pharmaceutical, Biotech, Laboratory, Science