Manager Analytical Sciences
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.
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
Job Summary
Reporting to the Associate Director, MS&T will be a member of a cross functional team that provides technical leadership for new and existing client QC testing and assay transfers. The Manager will manage the assay transfer and implementation process of all QC methods at the Memphis Manufacturing Facility. These duties may include assay troubleshooting and development. The incumbent is responsible for executing tech transfer activities and building processes to ensure consistent, timely, and efficient transfers. This role will serve as an SME for QC testing operations for new and existing clients.
- Responsible for all aspects of product transfer from the process establishment stage to commercial production following cGMPs. Responsible for ensuring that project objectives are achieved.
- Assists in the training and technology transfer of qualified flow cytometry assays to QC personnel.
- Assists in the training and technology transfer of qualified biological assays (ELISA, protein determination, etc) to QC personnel.
- Acts as SME for flow based and other biological assays.
- Responsible for ensuring that project timelines and client expectations are met or exceeded.
- Responsible for reviewing and analyzing data, designing subsequent experiments, and writing reports. This position will ensure a cohesive, integrated production environment, and ensure that the transfer of technology is thorough and well-coordinated.
- Responsible for the development and delivery of training materials to ensure that the operational, scientific, and analytical training of all employees involved with new processes/clients.
- Responsible for liaison with the Quality Control, Quality Assurance, Supply Chain, Project Management, Facilities, and other GMP Quality Control units.
- This position leads technology transfer by collaborating with clients and internal departments on establishing new, robust, and cost efficient testing needed for clinical and commercial manufacturing.
- Assists in creating relevant sampling and testing documents (sampling plans, job aids, SOPs, TSMs, etc) in a timely manner to facilitate the onboarding of new clients.
- May provide technical data or impact assessments for Deviations, CAPAs, or Change Control records.
Job Qualifications
- B.S. in an appropriate area of specialization and 4 years of appropriate experience; and/or training; or equivalent combination of education and experience. Experience working in a GMP laboratory or Medical Device/Manufacturing environment required.
- Experience (development, qualification, and execution) with Flow and Bioassays required
- Proficient with flow cytometry theory, instrumentation and experience in flow cytometry assays.
- Familiarity with FACS Canto II and BD FACSLyric flow cytometers or similar preferred.
- Demonstrated knowledge in “core” laboratory techniques (e.g. ELISA, cell culture/counting, PCR, etc.) and aseptic techniques required.
- Demonstration knowledge of immunology, cancer biology, and cell biology
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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 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 crrecruitment_US@crl.com. 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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