Celgene Senior Scientist, Downstream Process Development 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 Downstream Process Development will focus initially on a bispecific program, and 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, towards IND submission by the year end of 2017.
Responsibilities will include, but are not limited to, the following:
Design and develop downstream protein purification process and perform 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.
Supervise research and development staffs.
Lead technology/process transfer to internal or external manufacturers and 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 at or to CMOs for cGMP production, perform PIP for production support and troubleshooting.
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.
Work closely with cell-line development, upstream process development, analytical and formulation development groups to support discovery and preclinical development activities.
Work collaboratively with external partners to manage downstream process development programs and outsourced activities.
Write technical reports and present data/results to the project teams.
Ph. D., M.S. in biochemical/chemical engineering, biological sciences or relevant discipline with 6-8 years (Ph.D.) or > 10 years (M.S.) of industrial protein purification/downstream process development experience in production of recombinant therapeutic proteins
Hands-on experience with downstream process development, operations, process scale-up and technology transfer and associated analytical methods.
Strong scientific and engineering approaches to problem solving and process development.
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.
Demonstrated ability to function in a collaborative/team oriented R&D environment.
Good verbal and written communication skills. Able to communicate and connect with all levels of the organization.
Supervisory and leading project experience is necessary
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
Location: Summit, NJ, US
Job ID: 17000208