The Biologics Process Research & Development organization within our Research & Development Division is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics, and efficiently manufacture material to supply clinical trials. We are also responsible for late-stage process development and process characterization to prepare for commercial manufacturing. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.
Requirements
- Ph.D. with 6+ years of industry experience or Master with 8+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field
- Proven record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
- Experience in CHO fed-batch cell culture and a working understanding of downstream & analytics.
- Understanding and hands-on experience on cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities.
- Working knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics and computational fluid dynamics.
- Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
- Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors.
- Knowledge of biologics CMC development cycle.
- Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization.
- Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
- Demonstrated ability to develop staff to maximize utilization of talent and actively guides career development; builds strong and collaborative teams.
Benefits
- Comprehensive package of benefits, including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
