Senior Scientist - Downstream Process Development, mRNA

Senior Scientist – Downstream Process Development, mRNA

• Design and optimize IVT reactions, enzymatic processing, and purification workflows.
• Develop scale‑down models and execute DOE studies for process characterization and development.
• Author process development reports, validation protocols, and risk assessments (FMEA, CPP identification).
• Define a control strategy for mRNA drug substance (CPPs, CQAs, IPCs, acceptance criteria, sampling plans) and defend it through late‑phase / commercial readiness.
• Apply Quality by Design (QbD) principles and statistical tools for process characterization and PPQ readiness.
• Ensure compliance with FDA, EMA, and ICH guidelines for process validation and lifecycle management.
• Establish and maintain SOPs for mRNA synthesis and purification to ensure reproducibility and compliance.
• Collaborate with analytical teams for method development and validation of mRNA drug substance.
• Participate in tech transfer activities to GMP manufacturing sites for both mRNA and protein programs.
• Process scale chromatography and filtration (chromatography, tangential flow, normal flow) and operate, maintain, and troubleshoot chromatography workstations and process skids in an industrial setting.
• Process scale‑up, technology transfer, and viral clearance validation.
• Write standard operating procedures, batch records, and reports.
• Mentor junior staff regarding laboratory procedures and scientific projects.
• Perform other duties as assigned.

• Bachelor’s degree in a STEM discipline with 8–15 years of related experience, or
  • Master’s degree in a STEM discipline with 5–10 years of related experience.
  • Doctorate degree in a STEM discipline with 2–4 years of related experience.
• Experience with process scale chromatography and filtration (viral, chromatography, tangential flow, normal flow).
• Operating, maintaining, and troubleshooting chromatography workstations and process skids in an industrial setting.
• Viral clearance validation, process scale‑up, and technology transfer experience.
• Knowledge and experience working in a cGMP environment.
• Good documentation practices (GDP).
• Aseptic technique experience.
• Experience writing standard operating procedures, batch records, and reports.
• Experience mentoring junior staff regarding laboratory procedures and scientific projects.
• Deep knowledge of mRNA process development, including in vitro transcription (IVT), purification, and analytical characterization.
• Ability to support downstream process development for monoclonal antibodies and other protein modalities (preferred).
• Experience authoring or reviewing method validation/qualification strategy and understanding suitability for intended use (development vs GMP release) (preferred).

• 152 hours of PTO + 8 paid holidays.
• Generous 401(k) match.
• Medical, dental and vision benefits effective day one.
• Tuition reimbursement.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to Disabili with the job number, title and location included.