Scientist II, Downstream Process Development

Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options.

This Scientist position in Biologics Process Development will be responsible for the development of scalable purification processes, for research and Tox material production, and for scale up and transfer of processes to GMP facilities for clinical manufacturing of recombinant proteins and other novel biologics. Reporting to the head of the Downstream Process Development Group, the successful applicant will lead projects and should have a strong scientific approach to the development of scalable downstream manufacturing processes, the ability to establish mutual respect, trust, and close collaboration with internal and external partners, and the ability to communicate and connect with all levels.

* Perform downstream protein purification process development and process optimization of large molecule/recombinant proteins from traditional cell culture, microbial fermentation, or new and unconventional bioprocesses, including second generation therapeutic antibodies, antibody-drug conjugates, bi-specific antibodies and fusion proteins. * Conduct all aspects of downstream process unit operations, including conjugation and other reactions, centrifugation, depth filtration, chromatography, TFF, viral inactivation and viral filtration. * Develop robust and scalable protein purification processes for Celgene biologics candidates. * Execute process scale up and transfer to CMOs for cGMP production. * Develop downstream platform process including harvest/clarification, chromatography purification and UF/DF processes for Celgene biologics programs. * Develop high throughput screening methods and new technologies for process/method improvement. * Develop and perform analytical methods for in-process sample testing to support biologics early-phase process development and small/ pilot scale production. * Work closely with cell-line development, upstream process development, analytical and formulation development groups to support discovery and preclinical development activities. * Supervise and train associates. * Work collaboratively with external partners to manage early development programs and outsourced activities. * Write technical reports and present data/results to the project teams.

* Ph.D. in biochemical/chemical engineering, biological sciences or relevant disciplines with 3-5 years of industrial protein purification/ DSP development experience in production of recombinant therapeutic protein **Skills/Knowledge Required:** * Hands-on experience with continuous flow centrifugation, tangential flow filtration, and AKTA purification with preparative chromatography systems and Unicorn software. * Experience with process scale-up and technology transfer from development lab to pilot plant and into cGMP facilities. * Experience with HPLC/UPLC practical analytical chromatography, spectrophotometry, SDS-PAGE, Western-blot and ELISA methods. * Can adopt strong scientific and engineering approaches to problem solving and process development and optimization. * Able to introduce new technologies to improve and accelerate downstream process development and improve process efficiency * Knowledge of scale down model qualification, process optimization with risk analysis, FMEA methodology, and process characterization. Use of statistical experimental design and data analysis. * Knowledge and/or experience with automation experience in process setting and supervision is a plus. * Demonstrated ability to function in a collaborative/team oriented R&D environment. * Able to communicate and connect with all levels of the organization * Good verbal and written communication skills.