Scientist, Purification, RNA Process Development
About The Position
The RNA Purification Process Development function plays a central role in designing efficient, robust, and scalable manufacturing processes. By combining deep scientific expertise with enabling technologies and strong cross-functional partnerships, RNA Process Development delivers transformative innovation across the pipeline. The Scientist executes robust experiments for drug substance programs spanning early- to late-stage development across circular and linear mRNA modalities. Reporting to the Principal Scientist, this role encompasses hands-on contributions, addressing critical challenges by driving sound experimental execution and manufacturing support. The candidate should be driven by developing and characterizing chromatography and filtration steps for improving the yield, quality and robustness of purification process steps.
Requirements
- 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
- 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 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
Nice To Haves
- 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
Responsibilities
- Design, execute, and analyze experiments for existing and novel process modes using DoE and statistical modeling
- Define the RNA drug substance purification process, the critical parameters, and the design space
- Experiment using high throughput/automated or data rich experimental setups
- Design experiments to confirm robust process performance across the control space
- Collaborate with analytical teams to enable deeper characterization of RNA properties and impurity profiles
- Collaborate closely with upstream PD to characterize IVT feed stream to maximize RNA yield and purity
- Prepare technical reports, and communicate findings internally and externally as appropriate
- Participate in tech transfer activities to GMP manufacturing sites for RNA programs
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually for new hires
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
