Scientist, Purification, RNA Process Development

About the Role

The Scientist, Purification, RNA Process Development role at Bristol Myers Squibb is central to designing efficient, robust, and scalable manufacturing processes for drug substance programs. This role involves executing experiments for circular and linear mRNA modalities across early- to late-stage development.

Key Responsibilities

• Design, execute, and analyze experiments for existing and novel process modes using DoE and statistical modeling.
• Define the RNA drug substance purification process, critical parameters, and design space.
• Perform experiments using high throughput/automated or data-rich experimental setups.
• Design experiments to confirm robust process performance across the control space.
• Collaborate with analytical teams for deeper characterization of RNA properties and impurity profiles.
• Closely collaborate with upstream PD to characterize IVT feed stream to maximize RNA yield and purity.
• Prepare technical reports and communicate findings internally and externally.
• Participate in tech transfer activities to GMP manufacturing sites for RNA programs.

Requirements & Tech Stack

• Expertise in chromatography, filtration (TFF/UF-DF), and innovative separation unit operations.
• Solid knowledge foundation 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 for 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.

Qualifications

• Degree in Bio/Chemical Engineering, Bio/Chemistry, or related field.
• BS with 6+ years’ experience in science-related disciplines.
• MS with 4-6 years’ experience in science-related disciplines.
• PhD with 0 - 2 years’ experience in science-related disciplines.
• 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.