Scientist, Potency, CAR T Analytical Development

Req #: 1902742
Location: Seattle, Washington, United States
Job Category: Technical Development
Work Location: 400 Dexter Ave N. 98109
Organization: Bioengineering
Employee Status: Full-time
Job Type: Regular

The Potency Group is seeking a talented Scientist to lead projects that characterize the biological activity of autologous and allogenic cell therapies which are currently undergoing clinical trials, including CAR T cell products.

The Scientist will lead a team of 1-3 individuals who are developing analytical methods that evaluate the biological activity ( e.g. metabolism, proliferation, and effector function) of novel cell therapies. The successful candidate will facilitate the identification of new functional characterization methods to develop and oversee the design, execution, and analyses of experiments that lead to the development of robust analytical methods. These methods will be used to further understanding of cell therapies, support development of the manufacturing processes, and/or QC release of the drug product. The successful candidate will have a strong background in Immunology or related field and will have experience in projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. The Scientist will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists.

Qualifications and Education Requirements
• PhD with 2-6 years of experience in the field of Immunology, Cancer Biology, or related field, preferably in an industry setting.
• Expertise developing analytical methods that functional characterize T cells, such as their metabolism, proliferative capacity, and/or functional activity ( e.g. cytotoxicity, cytokine secretion, etc .)
• Experience with cell culture, ELISAs or similar technology platforms ( e.g. MSD, Luminex, AlphaLISA, etc .), and flow cytometry.
• Experienced with authoring and revising test methods, protocols, and technical reports.
• Demonstrated experience leading teams and managing direct reports.

Preferred Qualifications
• Experience with fluorescence microscopy, live cell imaging and analysis ( i.e. IncuCyte), and/or image cytometry
• Experience with molecular techniques, such as developing qPCR and next generation technologies such as NanoString, single cell RNA sequencing, and cellular indexing of transcriptomes and epitopes by sequencing (CITE-seq).
• High dimensional data analysis ( e.g. CytoBank, viSNE, SPADE, CITRUS, etc .).
• Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software.
• Proficiency with relative potency methods, 4-PL, robustness assessments, establishing system suitability criteria, critical reagent qualification procedures, analyst training, method transfers, and/or method qualification/validation.
• Demonstrated experience qualifying, transferring, validating, performance trending, and/or lifecycle management of analytical methods.

Specific Duties
• Emphasis on hands-on leadership, mentorship of direct reports, and fostering a creative, collaborative, and accountable working environment.
• Responsibility for the development of cell-based immunoassays and next-generation functional interrogation techniques.

• Proficiency with regulatory requirements, understanding of CMC strategy, awareness of industry trends, and advocate for new technologies.

About Us

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.