Associate Director, Cellular Process Development
Other Locations:US- NJ- Warren
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.Associate Director, Cellular Process DevelopmentWarren, NJ
Technical Operations, CCT
PhD or MS with relevant industrial experience
Key lead on all aspects of cell therapy process development towards rapid commercialization, including redefining processes to achieve improved characteristics, process characterization, data analysis, report writing, and regulatory filing activities. Make contributions related to various aspects of cell therapy process development including cell collection/isolation, cell expansion, medium design, harvest, formulation, and cryopreservation, as well as coordinate and supervise scientific and technical staff in these areas.
Responsibilities will include, but are not limited to, the following:
Primary role is a process development lead driving activities that support rapid commercialization of transformational cell therapies. Develop and execute plans ranging from feasibility to implementation for redefined manufacturing processes with dramatically improved cost, quality, scalability, and labor efficiency. Function as key scientific/engineering lead for a team of experienced process engineers Interface with Research and validation teams to generate and analyze process characterization data. Understand multinational regulatory and GMP requirements, interpret these to direct process development, and prepare materials for filings. Maintain and spread knowledge of current scientific literature and apply key concepts to project activities and plans. Provide process-related input to transfer and facilities designed for clinical or commercial supply. Interact extensively with Research, Process Development, Quality, Manufacturing, Regulatory, Pre-Clinical, and Clinical and other personnel as dictated by project need. Contribute in a team-oriented environment to achieve common project goals. Mentor staff to achieve their potential. Fully participate in divisional R&D activities and present detailed project up-dates as required.
- PhD in Biochemical Engineering or related discipline with 5 yrs R&D / process development experience, or MS with 10 yrs R&D / process development experience for cell therapies preferred.
- Solid understanding of the fundamentals of process development, tech transfer and validation.
- Familiarity with and constant attention to the evolving landscape through the literature, conferences, etc.
- Creativity to define the future of manufacturing for cell-based therapies
- Established track record of success and sound technical qualifications and knowledge in cell culture, cell process development, and GMP manufacturing.
- Excellent leadership, communication and presentation skills.