Principal Downstream Scientist – mRNA purification

Role Summary

Principal Downstream Scientist specializing in mRNA purification. You will design and optimize purification processes, collaborate with cross-functional teams, and contribute to the development of scalable solutions for mRNA vaccine platforms. This role is based in the United States.

Responsibilities

• Design, execute, and analyze experiments to develop and optimize mRNA purification processes.
• Ensure processes are scalable and phase-appropriate for clinical manufacturing.
• Collaborate with global teams, including analytical R&D, GMP, and process development colleagues.
• Drive innovative solutions to improve purification techniques and meet project milestones.
• Stay current with industry trends and emerging technologies in downstream processing.
• Maintain detailed documentation to ensure data integrity and compliance.

Qualifications

• Required: Master’s or PhD in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering, or a related field.
• Required: Five years (Master's) or Three years (PhD) of industry experience in downstream process development for large biomolecules, including mRNA or pDNA.
• Required: Three or more years of experience with purification techniques such as affinity capture, ion exchange, and hydrophobic interactions.
• Required: Three or more years of experience supporting CMC activities, including process and analytical development.
• Preferred: PhD in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering, or a related field.
• Preferred: Experience with Quality by Design principles and DOE studies for process optimization.
• Preferred: Knowledge of regulatory guidelines (FDA/ICH/ISPE) for process validation and technology transfer.
• Preferred: Familiarity with nucleic acid analytical technologies.
• Preferred: Strong problem-solving skills and ability to work collaboratively in a matrixed environment.

Education

• Master’s or PhD in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering, or a related field.
• PhD is preferred for the role.