Senior Scientist - Downstream Process Development, mRNA

Catalent Pharma Solutions•Madison, WI

1d•Onsite

About The Position

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.

Requirements

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 projects

Nice To Haves

Experience authoring or reviewing method validation/qualification strategy and understanding suitability for intended use (development vs GMP release)
Ability to support downstream process development for monoclonal antibodies and other protein modalities

Responsibilities

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.