Celgene Senior Scientist, Downstream Process Development - Process Analytics in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
This Sr. Scientist position in Biologics Process Development will be responsible for the analytical method transfer and establishment as well as analytical testing for the biologics process samples to support cell-line development (CLD), upstream and downstream process development in development lab. Reporting to the head of the Downstream Process Development & Process Analytical Support Group, the successful applicant will lead the Process Analytical Support (PAS) team to maintain the PAS lab function and perform all of PAS activities including coordinating sample submission/testing/result interpretation/distribution and should have a strong scientific approach for biologics analytical technologies, 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.
Responsibilities will include, but are not limited to, the following:
Lead all process analytical testing activities including analytical method transfer, optimization and qualification, method trouble-shooting and sample testing to support CLD and process development (PD).
Conduct all analytical testing for biologics process samples using HPLC/UPLC chromatography, capillary electrophoresis(CE), image CE, qPCR recombinant DNA assay, host-cell protein (HCP) assay, Glycan profile analysis and kinetic binding analytical method.
Establish assay protocols and prepare technical reports, and present data/results to the project teams.
Lead sample forecast meeting and coordinate with CLD and PD groups for sample testing planning, interpreting testing data in conjunction with an electronic lab notebook.
Manage and organize the PAS lab activities including instrument maintenance and calibration.
Perform high throughput analytical methods and new technologies to reduce sample testing turnaround time.
Develop and perform analytical methods for in-process sample testing to support biologics process development and small/ pilot scale production.
Supervise and train associates and junior scientists.
Work collaboratively with external partners to manage early development programs and outsourced analytical activities.
Ph. D. with 6-8 years, or M.S. with > 10 years of industrial biologics process analytical methodologies and protein characterization experience in production of recombinant therapeutic proteins
Skills/Knowledge Required :
Hands-on experience with protein/antibody characterization, analytical method development, optimization and qualification as well as analytical method transfer.
Experience with HPLC/UPLC practical analytical chromatography, CE, iCE, qPCR, glycan profiling technologies, HCP-ELISA, protein/antibody kinetic binding, spectrophotometry methods
Strong problem solving skills by strong scientific and engineering approaches
Able to introduce new technologies to improve and accelerate analytical sample testing and improve sample through-put.
Knowledge and/or experience with automation experience in analytical method setting, biologics process development and use of statistical experimental design and data analysis is a plus.
Demonstrated ability to function in a collaborative/team oriented environment.
Good verbal and written communication
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Senior Scientist, Downstream Process Development - Process Analytics
Location: Summit, NJ, US
Job ID: 17000728