Job Description: Req #: 1803157
Location: Warren, New Jersey, United States
Job Category: Technical Development
Work Location: 7 Powder Horn Drive 07059
Employee Status: Full-time
Job Type: Regular
The Senior Associate Scientist will work within our Product Science group, a part of Cell Therapy Development & Operations (CTDO) at Celgene. The candidate will design and execute complex experiments to characterize CAR T cell products, and support the activities related to the identification of product critical quality attributes. This role will also develop novel analytical methods to enhance the biological understanding of cellular therapy products. The candidate is expected to have a scientific understanding of T cell biology and skills to carry out a spectrum of immunology techniques related to cellular product assays. The candidate should be independent and result-oriented with good communication skills, and willing to work in a fast-paced work environment.
Responsibilities will include, but are not limited to, the following:
Perform experiments of moderate complexity under minimum supervision in support of analytical development and characterization of starting material, intermediate product and final product.
Design experiments to identify and test new analytical methods as part of process improvement for existing products, as well as the development of new products for CAR-T therapies.
Identify, evaluate, and onboard new cell-based analytical methods to support extended characterization of CAR-T cell products.
Author and review analytical test methods, assay development reports, and assay qualification reports.
Contribute to the preparation of regulatory documents (INDs, IMPDs, Briefing Documents, BLAs, MAAs)
Support team members through teamwork and collaboration.
Mentor and train research associates in the development and execution of cell-based assays.
Ensure proper operation and perform routine maintenance of laboratory equipment.
Maintain a safe workplace in accordance with company and OSHA policies/procedures.
MS. in immunology, cell biology, molecular biology, biomedical engineering, biological science, or related discipline with 1-2 yrs+ relevant experience, or BS with 3-5 yrs+ relevant experience in biopharmaceutical development for cell therapies/biologics. Expertise and experience in adoptive T cell therapy preferred.
Scientific understanding of immunology.
Knowledge of analytical development.
Hands-on experience in flow cytometry, mammalian cell culture, PCR and ELISA/Luminex-based assays.
Ability to write technical protocols, reports and SOPs.
Excellent organization skills and the ability to handle multiple tasks.
Excellent verbal and written communication skills.
High motivation and drive to acquire new skills.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.