Senior Scientist - Downstream Process Development, mRNA

Senior Scientist - Downstream Process Development, mRNA

Position Summary:

• Work Schedule: M-F 8am-5pm
• 100% on-site

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Catalent Pharma Solutions in Madison, WI is hiring a Senior Scientist - Downstream Process Development, mRNA. The Process Development Senior Scientist, mRNA will lead and support the development, optimization, and process characterization of manufacturing processes for mRNA-based therapeutics and vaccines, spanning early-phase clinical through commercial programs. This role requires hands-on expertise in mRNA process development, including in vitro transcription (IVT), purification, and analytical characterization.

The scientist will bring deep mRNA technical expertise and demonstrate continuous learning and adaptability, recognizing that supporting multiple modalities, including protein biologics, may be required to meet evolving client and business needs.

The Role:

• Design and optimize IVT reactions, enzymatic processing, and purification workflows
• Develop scale-down models and execute DOE studies for process characterization and process development
• Author process development reports, validation protocols, and risk assessments (FMEA, CPP identification)
• Define a control strategy for mRNA DS (CPPs, CQAs, IPCs, acceptance criteria, sampling plans) and defending 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. Experience authoring or reviewing method validation/qualification strategy and understanding suitability for intended use (development vs GMP release) preferred
• Ability to support downstream process development for monoclonal antibodies and other protein modalities preferred.
• 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) experience
• Operating, maintaining, and troubleshooting chromatography workstations and process skids preferably in an industrial setting
• Process scale up and technology transfer
• 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
• Other duties as assigned.

The Candidate:

• Bachelor's degree in a STEM discipline and 8-15 years related experience, OR
• Master's degree in a STEM discipline and 5-10 years related experience, OR
• Doctorate Degree in a STEM discipline and 2-4 years related experience
• Process scale chromatography and filtration (viral, chromatography, tangential flow,
  normal flow) experience
• Operating, maintaining, and troubleshooting chromatography workstations and process
  skids preferably in an industrial setting
• Viral clearance validation, process scale up, and technology transfer
• 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 project

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for…