Job Advertisement: Senior Scientist Upstream Process Development

Location: Gaithersburg, MD

Client 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 Senior Scientist 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.