Job Description:

Job Advertisement: Scientist II, Upstream Process DevelopmentScroll down to find the complete details of the job offer, including experience required and associated duties and tasks.Location: Gaithersburg, MDClient Overview:Our client, a leading biotechnology company in Gaithersburg, MD, is seeking a dedicated Scientist to join their Upstream Process Development Department. This is an exciting opportunity to contribute to the development of innovative vaccines and therapies in a dynamic and collaborative environment.Position Overview:As a Scientist II in the Upstream Process Development Department, you will be responsible for leading the design, optimization, and scale-up of upstream processes. This role requires hands-on experience in the laboratory and pilot scale-up facility, focusing on process development, characterization, and scale-up. The ideal candidate will possess strong organizational skills, a high level of motivation, and the ability to deliver scientifically sound solutions to complex challenges.Key Responsibilities:Develop robust, high-producing, scalable, and economically viable cell culture production processes, up to large-scale bioreactors.Optimize and scale-up fed-batch bioreactor processes, including evaluating different cell culture media and feed formulations.Lead efforts to evaluate optimal feeding strategies to improve product yield, quality, and purity.Complete process robustness and characterization studies for technology transfer to manufacturing plants.Support process validation activities, including protocol writing, execution, and report writing.Perform and analyze Design of Experiment (DOE) studies to fully characterize processes.Generate, manage, evaluate, and maintain critical data in an organized manner.Present experimental results to team members and across functional groups.Minimum Requirements:PhD with 2-5 years directly related industry experience, MS with 6-8 years directly related industry experience, or BS with more than 10 years of directly related industry experience.Experience with developing fed-batch bioreactor processes and optimizing feeding strategies.Extensive experience with small-scale and large-scale cell culture bioreactor process development.Hands-on experience in the operation of single-use bioreactors up to pilot scale.Demonstrated experience in process development, including the use of statistical design of experiments.Working knowledge of Cell Clarification/Harvest and Downstream purification is a plus.Excellent verbal and written communication skills.Ability to critically analyze data using statistical tools.Experience with JMP or similar software is a plus.Knowledge of process characterization and validation of biological products.Practical experience with single-use disposable equipment applications for biomanufacturing.Comfortable working in a fast-paced environment and collaborating in cross-functional teams.