Scientist, Downstream Process Development

Position Summary:

Orbital is seeking a purification Scientist to join the Process Development group to support the development, scale-up and tech transfer of first-in-class RNA-based therapeutics. The candidate should be driven by developing and characterizing chromatography and filtration steps for improving the yield, quality and robustness of downstream process steps. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment. The successful candidate will possess strong skills in designing and executing high quality bioprocess experiments using Quality by Design (QbD) and Design of Experiment (DoE) methods. The person in this role will have the opportunity to establish process analytics, process models and support process investigations. This role will give regular updates in the form of presentations and reports which are communicated to cross-functional research and CMC teams.

Responsibilities: 

• Design, execute, and analyze experiments for existing and novel process modes using DoE and statistical modeling.
• Define the process, the critical parameters, and the design space.
• Create high throughput and automated experimental setups.
• Lead experiments to confirm robust process performance across the control space.
• Characterize RNA properties through collaboration with the analytical team.
• Prepare technical reports and communicate findings internally and externally as appropriate.

Qualifications: 

• B.S./M.S. (with 10+ years) or Ph.D. (with 1-3 years) in Bio/Chemical Engineering, Bio/Chemistry, or related field.
• Expertise in chromatography, filtration, and innovative separation unit operations.
• Working knowledge of statistical design of experiments (DoE) and analysis of multivariate data.
• Experience with performing process analytics and biophysical characterization techniques such as HPLC, CE, & gel electrophoresis.
• Knowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and clinical manufacturing.
• Demonstrated background of providing technical support for clinical manufacturing processes, including support of process investigations, and implementation of proactive process modifications.
• Knowledge of advanced mathematics, nucleic acid chemistry, lipid chemistry, and biology is a plus.
• Knowledge of establishing and qualifying scale down models and mechanistic models for process characterization is a plus.